MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE AND NEEDLE COMBINATION LUER-LOK¿¿ TIP; HYPODERMIC SYRINGE AND NEEDLE

Catalog Number 309634

Device Problems Moisture Damage (1405); Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7002757.Medical device expiration date: 12/31/2021.Device manufacture date: 01/02/2017.Medical device lot #: 7338665.Medical device expiration date: 11/30/2022.Device manufacture date: 12/04/2017.Medical device lot #: 6307994.Medical device expiration date: 10/31/2021.Device manufacture date: 11/02/2016.Medical device lot #: 8010589.Medical device expiration date: 12/31/2022.Device manufacture date: 01/10/2018.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 syringe and needle combination luer-lok¿ tip had moisture and black flakes within the syringe.Found before use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: sample evaluation: total 207 samples were received from 7 batches.2 sealed 5ml 22g luer-lok syringes confirmed to be from batch #7193596 (p/n 309631).2 sealed and 1 opened empty package of 5ml 20g luer-lok syringes confirmed to be from batch #6307994 (p/n 309634).1 sealed 5ml 20g luer-lok syringe confirmed to be from batch #7002757 (p/n 309634).23 sealed and 1 opened empty package of 5ml 20g luer-lok syringes confirmed to be from batch# 8010589 ( p/n 309634).11 sealed of 5ml 20g luer-lok syringe confirmed to be from batch# 7310985 (p/n 309634).83 sealed 5ml 20g luer-lok syringes confirmed to be from batch# 7338665 (p/n309634).76 sealed, 1 opened and 1 opened empty package 5ml 20g luer-lok syringes confirmed to be from batch# 8010590 (p/n 309634).5 loose 5ml syringes from unknown batch# and p/n.Samples were visually evaluated.30 syringes were randomly selected for closer evaluation.Their packages were opened and samples evaluated.A small amount of silicone was observed on the stopper in the samples.The amount of silicone observed was a normal and expected amount for this product per product specification.One package from batch 7338665 had a small unidentified black flake fm loose in the package on the outside of the needle shield, it was less than level 3 in size which is acceptable condition per specification.No defects were confirmed during evaluation.Dhr review for batch 7002757 (p/n 309634): manufacturing dates: 02/10/2017 to 02/11/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7002757 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 7338665 (p/n 309634): manufacturing dates: 12/09/2017 to 12/10/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7338665was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 6307994 (p/n 309634): manufacturing dates: 12/04/2016 to 12/05/2016.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6307994 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Dhr review for batch 8010589 (p/n 309634): manufacturing date: 01/12/2018.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 8010589 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: root cause and capa not required as no defects were confirmed.

• Brand Name: BD SYRINGE AND NEEDLE COMBINATION LUER-LOK¿¿ TIP
• Type of Device: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7374184
• MDR Text Key: 103797736
• Report Number: 1213809-2018-00175
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096343
• UDI-Public: 00382903096343
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309634
• Device Lot Number: SEE H.10.
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other