MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER LOK¿ SYRINGE; HYPODERMIC SYRINGE

Catalog Number 309702

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the bd luer lok¿ syringe there are missing and distorted graduation marks on the syringes.There was no further report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: bd received (b)(4) sample bags of 260 loose 3ml assembled syringes and reported to be from batch # 7146876 (p/n 309702).The samples were visually evaluated.(b)(4) syringes were found to have no defects or acceptable cosmetic defects per product specification.(b)(4) syringes were found to have rejectable defects: (b)(4) syringes had ink smears and missing print of rejectable quality.(b)(4) syringes had minor surface damage causing missing print of rejectable rating on the barrel in the direction parallel to the length of the barrel.(b)(4) syringe was found to be cracked from the barrel roof to about the 1ml grad line.Dhr review for batch 7146876 (p/n 309702): manufacturing dates: 06/05/2017 ¿ 06/24/2017.Batch quantity was (b)(4).Batch marking and assembly records were reviewed as part of this dhr review.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.The packaged product was assembled on two separate assembly machines.A clogged manifold and an ink spill were recorded on one of the subassembly batches resulting in the marker adjustments, ink replacement and down time.Batch 7146876 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment confirmed: bd was able to confirm the customer¿s indicated failure.Investigation conclusion: potential root cause: (1) ink smears and missing print - these defects were likely caused by an interruption in ink flow due to a clogged manifold.The inconsistent ink flow likely caused a transferring issue of ink to the gravure cylinder and subsequently to the printing pad.(2) missing print due to surface damage ¿ likely due to a temporary part jam at an assembly machine.As printed barrels move past the jammed part they may have part of their print scratched off by it.(3) cracked barrel ¿ the barrel got cracked at one of the pinch points between the marker and the packaging machine.

• Brand Name: BD LUER LOK¿ SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7154378
• MDR Text Key: 96347521
• Report Number: 1213809-2017-00406
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903097020
• UDI-Public: 30382903097020
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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: 05/31/2022
• Device Catalogue Number: 309702
• Device Lot Number: 7146876
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/29/2017
• Supplement Dates Manufacturer Received: 12/07/2017
• Supplement Dates FDA Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other