MAUDE Adverse Event Report: BD CARIBE, LTD BD CD5 PERCP-CY5.5 L17F12 ASR; REAGENTS, SPECIFIC, ANALYTE

Model Number 341099

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported by the customer that the bd cd5 percp-cy5.5 l17f12 asr had one bottle with no label or missing label information (all reagent packaging levels).Additional information (b)(6)2022 the event type associated with this complaint is being used with an asr reagent that is for assay specific testing.Sun min lee : (b)(6)2022 15:55:40 (gmt) (b)(6), bd sales team reported as below."(b)(6) at the univ of kansas reported yesterday evening that on po-(b)(4), 1 bottle of item # (b)(4) came with no label on it.We cannot use this.Can bd provide a foc replacement? " they received 41 qty of this lot vials and one bottle came with no label.Sent one vial foc of the same lot: foc po# (b)(4).Delivery date will be july 6th due to holiday shipping schedule.Sun min lee : (b)(6) 2022 15:52:14 (gmt).One bottle of this reagent came with no label on it.

Manufacturer Narrative

H.6 investigation summary scope of issue: the scope of issue is limited to part # 341099 and lot 2055846.Problem statement: customer reported complaint on (b)(6) 2022 that received one bottle of product 341099 and lot 2055846 (cd5 percp-cy5.5).Picture showed vial with an apparent removed label, leaving a blank defaced label affixed to the vial.Customer bought a total of 41 vials, only one showed the defect.¿manufacturing defect trend: there are zero qn(s) related to the reported issue in the examined period from (b)(6) 2021 to date (b)(6) 2022.Batch history record (bhr) review: bhr part 341099 lot 2055846 was reviewed as part of this investigation.The materials met all the manufacturing specifications prior to release.Total manufactured quantity was (b)(4) vials.Br documented 14 parts that underwent rework process.Rework is performed when a label needs to be replaced for any condition such as alignment, placement, and legibility among others.Final label is removed and a new label is applied to correct the defect.A 100% visual inspection, part of the manufacturing process, was performed and did not detect any discrepancies.Aql sample inspection was performed and determined the lot to be in compliance.Vials were shipped to plant 1149 for further distribution.Complaint history review: there is one complaint(s) related to the reported complaint.Date range (date of incident to 12 months back) from date (b)(6) 2021 to date (b)(6) 2022; (this complaint).Retain sample analysis: the retain sample for the 91-stage (91- 0569pr, lot 2033552) was visually inspected as retains of the final labeling are not maintained.At the 91-stage, the vial does not have its final label but other labeling information such as cap top printing was verified.The cap top printing was determined to be present and correct.The result was acceptable.Returned sample analysis: the sample was not requested to be returned because photo was provided.The photo was evaluated, and the result showed the claimed defect.Risk review: risk management file part 100311, revision 09 was reviewed.Hazard(s) identified? yes if no (to above), what actions will be taken? hazard id#: 4.2.Hazard: information hazard.Cause: missing label or label information.Harmful effects: unable to perform testing or delay of test results.Severity: 3.Probability: 1.Risk index: 3.Implementation: verified by label approval process, verified by production record.Risk control: label approval system validation.Effectiveness verification: verified by label approval process, verified by protocol.New hazard: none.Mitigation(s) sufficient: yes.If no (to above), what actions will be taken? root cause analysis: based on the investigation, the possible root cause was incomplete reworked sample.No additional events have been reported as of 31aug22.It is determined that claim is confirmed but no corrective action is required at this time per (b)(4) as the identified process opportunities that might have contributed to the event were addressed in new (b)(4) revision (revision 16).Bd will continue to monitor for related claims.Conclusion: based on the investigation result, complaint was confirmed but further actions are not necessary.Capa determination and rationale if capa is not required determined risk for this event is considered low based on the severity and occurrence of the event as per (b)(4), hence capa is not required.

Event Description

It was reported by the customer that the bd cd5 percp-cy5.5 l17f12 asr had one bottle with no label or missing label information (all reagent packaging levels).Additional information 07/08/2022: the event type associated with this complaint is being used with an asr reagent that is for assay specific testing.(b)(4) : 2022-07-01 15:55:40 (gmt).(b)(4), bd sales team reported as below."(b)(6) at the (b)(6) kansas reported yesterday evening that on po-10266255, 1 bottle of item # 341099 came with no label on it.We cannot use this.Can bd provide a foc replacement? " they received 41 qty of this lot vials and one bottle came with no label.Sent one vial foc of the same lot: foc po# 5007411348.Delivery date will be july 6th due to holiday shipping schedule.(b)(4) : 2022-07-01 15:52:14 (gmt).One bottle of this reagent came with no label on it.

• Brand Name: BD CD5 PERCP-CY5.5 L17F12 ASR
• Type of Device: REAGENTS, SPECIFIC, ANALYTE
• Manufacturer (Section D): BD CARIBE, LTD; vicks drive; lot no. 1; cayey
• Manufacturer (Section G): BD CARIBE, LTD; vicks drive; lot no. 1; cayey
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15076496
• MDR Text Key: 304807547
• Report Number: 2647876-2022-00170
• Device Sequence Number: 1
• Product Code: MVU
• UDI-Device Identifier: 00382903410996
• UDI-Public: 00382903410996
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 341099
• Device Catalogue Number: 341099
• Device Lot Number: 2055846
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2022
• Initial Date FDA Received: 07/21/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1