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Event verbatim [preferred term] cut his thumb [skin laceration], the winged part from the thrombin-jmi syringe spray kit broke off [syringe issue].Case narrative: this is a spontaneous report from a contactable nurse via pfizer sales representative.This male nurse of unspecified age, reporting for himself, received absorbable gelatin (gel-flow nt) and thrombin (thrombin jmi, syringe spray kit 5000 units) on an unknown dates; each with unspecified route of administration, dose, frequency and indication.The patient's medical history and concomitant medications were not reported.The patient was reconstituting gel-flow kit when the winged part of the 10ml syringe from the thrombin-jmi syringe spray kit broke off and cut his thumb.This happened earlier on 06may2019 at hospital.The event did not take place after use of the product.The action taken and outcome was unknown.On 27jun2019, investigation report received from product quality complaints group.Reasonably suggest device malfunction: yes.Severity of harm: s2.Failure mode: h01-06 incorrect product output/function.Idc - level 1: quality, idc - level 2: product complaint, idc - level 3: complaint - function / therapeutic properties, delivery system (ds): kit: gelfoam powder in syringe co-packaged with thrombin root cause analysis/identif: root cause: pfizer (site name redacted) quality operations could not determine a probable root cause for the reported complaint related to the site production process.Examination of a returned complaint sample may have aided in the identification of a root cause.A review of aprr reports, deviations, and an evaluation of trends indicated that all gelflow batches relevant to this investigation had met established requirements at the time of release.It is unknown how the reported complaint sample was handled, stored, or used after leaving the (site name redacted).Impact analysis: quality of batch: acceptable.Based upon the results of this investigation, pgs-qo site concludes that the quality of the product on the market remains acceptable.Root cause category (tier 1): non-assignable (complaint not confirmed).Root cause category (tier 2): non-assignable (complaint not confirmed).Root cause category (tier 3): n/a contributing factor (tier 3): n/a special or common cause: common cause root cause is always present to some degree in the process.Special cause root cause is something different happening at a certain time or place in the process.Common cause.Improve/control: corrective / preventive action: corrective action: pfizer (site name redacted) quality operations and production have been notified with the details of the reported complaint.No corrective or preventative have been identified as a result of this investigation.The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported product for distribution.Conclusion and approvals: additional approval(s) req'd, product quality impact, market / clinical impact, sqrt review required, stability impact: no.Conclusion: the review of all records within scope of this investigation demonstrated the acceptability of the product over the timeframe within scope.The worst case severity for the reported malfunction as determined from risk documentation for the product is s2; therefore pfizer us safety was not notified, and no regulatory notification is required.The details of the reported complaint have been forwarded to the pgs (site redacted) mdcp team for evaluation.Further action by pfizer site is not required.Batch /process record review: scope of compl.Investigation: scope: all gelflow kits packaged within the 24 months prior to the receipt of the reported complaint were queried within pcom, and all complaints found were examined against the reported complaint narrative and complaint classification.There were no previously received complaints with a known batch number determined to be within scope.This relates to medical devices.Deviations, laboratory investigation reports (lir), and change management (cm) records for all batches in aprrs and the site deviation tracking system for 24 months prior to the receipt of the reported complaint were reviewed.A deviation was not initiated for the reported complaint; however, the following were found through a review of previous deviations, lir, and cm for the timeframe in scope.Packaging records: complete - acceptable vials of thrombin and diluent are received by pfizer (b)(4) from [manufacturing site].Kits of thrombin jmi are assembled by pfizer kdp into a kit tray.A vial of thrombin and a vial of diluent are placed into a tray along, with a syringe, a safety needle-mixing device, and a diluent straw.The kit is then sealed, and sent for terminal sterilization.Gelflow nt cartons are manufactured externally by (redacted) and received by pfizer site.The peel pouch containing the pre-filled syringe is removed from the carton.A gelflow nt pouch, a sterilized thrombin jmi kit, a product insert for gel-flow nt, and a product insert for thrombin jmi are then packaged into each gel-flow kit finished goods carton.The cartons are not sealed during packaging.Audits are performed on the finished packaged units at regular intervals throughout the final packaging process.Process control evaluation: n/a process controls were reviewed as a part of this investigation.Per correspondence with par, the contract manufacturer of thrombin, a 100% inspection of vials is performed prior to delivery to pfizer site.A 100% inspection occurs as a part of the kitting of thrombin.Additionally, an aql inspection of 800 vials is performed to confirm the thoroughness of the 100% inspection process.During kitting of the gelflow kit, a 100% verification of component presence is performed for the thrombin kits.Notification to the medical device combination product (mdcp) team was not needed for evaluation of process controls; however, the details of the reported complaint were forwarded to the mdcp team as required by procedure.Qo batch history report: complete - acceptable.The batch number for the reported complaint is unknown; therefore, an evaluation of the batch history could not be performed as a part of this investigation.An examination of retained reference samples could not be performed for the complaint, as the complaint is for an unknown batch.Additionally, there were no previously investigated complaints for which an evaluation of previous retained reference sample examinations could be reviewed.The batch number for the reported complaint is unknown; therefore, an evaluation of previous complaint history for a batch could not be performed as a part of this investigation.These fields are provided for investigating sites to document other trending requirements as needed.(i.E., a review of site investigations related to the lot(s) in scope, and any broader trend investigations related to this complaint, etc.) medical device report review: complete-acceptable.A review of all previous medical device reports (mdr) was performed as a part of this investigation.There were no previous mdr relevant to the reported complaint; therefore, the reported complaint was not escalated to pfizer us safety as a repeated mdr occurence.Medical device trend analysis: complete-acceptable.The complaint history for all absorbable material product category complaints received classified as 'ddsc - component' and 'delivery system' was evaluated for potential trends.The following parameters were used.The results of the above query were further evaluated by date contacted, and then also by the classification 'ddsc - component' and 'delivery system'.There was a month that included a higher than normal number of complaints; however, this was due to the receipt of (b)(4) complaints in jan2019.A review of each complaint investigation determined that there was no impact to the quality of product, and the quality of product remains acceptable.Additionally, the results of the above query were further evaluated by date contacted, and then also by a sub-class of 'does not operate as indicated'.There was a month that included a higher than normal number of complaints; however, this was due to the receipt of the single reported complaint that is being investigated here.No negative trend in regards to product quality was identified.Pgs site did not receive a returned complaint sample, or photographs, for evaluation.On 04oct2019, additional information was received from the product quality complaint group: the severity of harm was reported as s3.On 04oct2019, 17oct2019 and 22oct2019, additional information was received from the product quality complaint group: complaint class was external cause investigation and complaint sub-class was adverse event/serious/unknown; samples and photos were not available, site sample status: not received, final confirmation was not confirmed.Conclusion: based on the complaint description, the patient sustained a cut on the thumb when part of the product broke during use.Review of complaint description concludes there is a device malfunction.Confirmed that severity level was s3 based on hal's severity ranking.This record has unknown lot/batch number therefore determination of whether similar cases have occurred before is difficult to assess.Based on the limited information we have, p2 value assessed be "0".Follow-up (27jun2019): new information received from product quality complaints group included: investigation report.Follow-up (26aug2019): follow-up attempts are completed.No further information is expected.Follow-up (04oct2019): new information received from product quality complaints group included: severity of harm updated to s3 (previously reported as s2).Follow up attempts are completed.No further information is expected.Follow-up (04oct2019, 17oct2019 and 22oct2019): new information received from product quality complaint group included investigation report (confirmed that severity level was s3 and concludes there is a device malfunction, p2=0).Company clinical evaluation comment: the reported event coded as syringe broken and laceration of thumb did not cause serious injury in this patient.This is a single potential device malfunction which has a theoretical risk to cause serious injury (injury to user may need medical intervention) to user, if it were to recur.The company conducted an investigation, and there were no previous mdr relevant to the reported complaint.Medical device trend analysis: complete-acceptable.Follow-up attempts are completed.No further information is expected., comment: the reported event coded as syringe broken and laceration of thumb did not cause serious injury in this patient.This is a single potential device malfunction which has a theoretical risk to cause serious injury (injury to user may need medical intervention) to user, if it were to recur.The company conducted an investigation, and there were no previous mdr relevant to the reported complaint.Medical device trend analysis: complete-acceptable.
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