MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2; SPINAL NEEDLE

Catalog Number 408381

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/03/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 that the bd¿ needle for spinal anesthesia detached during removal, in the patient¿s spinal column.A piece of the needle remained in the column and required x-ray and surgical removal.

Manufacturer Narrative

Additional information received from customer on 17.July.2018: the only permanent damage is the scar in the patient's lumbar region, resulting from the surgery performed to remove the needle.Patient is fine, no complaints.After the occurrence, there was a need for imaging exams (x-ray in the operating room) and surgery to remove the needle.The patient was seated and sedated during the spinal anesthesia procedure.After the event, it was carefully positioned with the aid of all the team in position of lateral decubitus position and later in the ventral decubitus for the accomplishment of the surgery in order to withdrawal the needle by the neurosurgeon on duty.The material was removed by a neurosurgeon who checked the positioning of the needle with the x-ray and subsequently performed an incision in the patient's lumbar region, identifying the needle after incision in the subcutaneous tissue.Possibly the patient would be discharged on the same day of the procedure (varicose vein surgery), but after that she remained hospitalized during that day and was discharged the next day.Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: a.3.Sex: female.B.2.Event attributed to: required intervention.D.8.Device single use?: no.H.3.Device returned to manufacture: yes.Investigation summary: one sample of catalog 408381 lot 8038713 were received in bd (b)(6) for evaluation on 06aug18.The sample received is from cavity 1 and it was observed a bent on loose part of the cannula.Thus, stylet showed a bent on same point of cannula rupture.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of needle broken with lot #8038713 regarding item #408381 a review of the device history record was completed for the bd juncos 405155 lots 7013875 and 7044833 used on bd brazil 408381 lot 8038713.The sub-assembly material number: 700006013, spinal needle 27 x 3 1/2in quincke- bulk.Lot 7013875.Manufactured from 11jan17 to 12jan17 on insert molding machine tic #5 under production order 101207335 lot 7010796.This lot comprises six (6) manufacturing shifts in which in process inspections were performed at shift start up on 32 samples (8 samples per cavity) and every 4 hours on 16 samples (4 samples per cavity) for cannula inspection which covers cosmetic appearance of cannula/stylet, angularity; among other visual characteristics and functional as pull force test that is performed on 16 units (4 p/cavity) on shift start-up and 8 units (2 p/cavity) every four hours.Final inspection as per bdm0180 was performed on 17jan17 for required testing as per product specification sp1789.Inspection performed by quality inspector included visual, dimensional and functional testing.Specific for the detection of defect cannula using 0.65% aql lii on 500 samples.Moreover, functional pull force test on needle was performed on 20 samples using a single s3 level, aql 0.40% with acceptable results.No ncmr nor machine interventions were reported by this lot.The lot was released for packing on 18jan17 and was packed as bulk non-sterile catalog number 405155 lot 7013875 production order# 101210938.A total of 46,400 units were released for shipping on 23jan17.The expiration date for this lot is 31jan2022.Lot 7044833: manufactured from 17feb17 to 20feb17 on insert molding machine tic #5 under production order 101241653 lot 7044757.This lot comprises nine (9) manufacturing shifts in which in process inspections were performed at shift start up on 32 samples (8 samples per cavity) and every 4 hours on 16 samples (4 samples per cavity) for cannula inspection that covers cosmetic appearance of cannula/stylet, angularity; among other visual characteristics and functional as pull force test that is performed on 16 units (4 p/cavity) on shift start-up and 8 units (2 p/cavity) every four hours.Final inspection as per bdm0180 was performed on 21feb17 for required testing as per product specification sp1789.Inspection performed by quality inspector included visual, dimensional and functional testing.Specific for the detection of defect cannula using 0.65% aql lii on 500 samples.Moreover, functional pull force test on needle was performed on 20 samples using a single s3 level, aql (b)(4) with acceptable results.No ncmr were reported by this lot.Machine intervention reported was regarding molding at station 8 for cavity 3.This machine intervention is unrelated to the reported failure of needle broken.Thus, complaint sample is cavity 1, which machine interventions for this cavity was not reported.The lot was released for packing on 22feb17 and was packed as bulk non-sterile catalog number 405155 lot 7044833 production order# 101241826.A total of (b)(4) were released for shipping on 28feb17.The expiration date for this lot is 28feb2022.Preventive maintenance on the tic# 5 machine was conducted as per schedule lots 7013875 and 7044833.Review of instrument calibrations as per inspection records was conducted and they were calibrated within their calibration due dates.Summary: the manufacturing records were reviewed for the incident lots and no discrepancy or related non-conformance were identified that could have contributed to the reported condition.No incidents related to broken needle or low pull force were reported during in-process or final inspections.Potential root cause can be directed to possible handling issues based on the evaluation of the sample received.Sample have a notable bend on cannula and stylet in which can be an indicative to bending & restraightening mode of failure.No possible cause has been identified for this complaint related to juncos manufacturing process within this investigation.However, per sample evaluation most possible root cause is handling issues.

Event Description

It was reported that the bd¿ needle for spinal anesthesia detached during removal, in the patient¿s spinal column.A piece of the needle remained in the column and required x-ray and surgical removal.

• Brand Name: BD NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 7740348
• MDR Text Key: 115727708
• Report Number: 9610048-2018-00101
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 408381
• Device Lot Number: 8038713
• Initial Date Manufacturer Received: 07/12/2018
• Initial Date FDA Received: 08/01/2018
• Supplement Dates Manufacturer Received: 07/12/2018
• Supplement Dates FDA Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR