MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ SYRINGE; PISTON SYRINGE

Catalog Number 301033

Device Problems Break (1069); Failure to Align (2522); Contamination /Decontamination Problem (2895); Device Markings/Labelling Problem (2911); Material Integrity Problem (2978)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7262531, medical device expiration date: 09/30/2022, device manufacture date: 09/19/2017.Medical device lot #: 7353646, medical device expiration date: 12/31/2022, device manufacture date: 12/19/2017.

Event Description

It was reported that multiple bd luer-lok¿ syringes were found with particulate matter contamination, product damage, excess lubricant, scale marking issues, inclusions, and a misaligned gasket.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Dhr- there was no documentation of issues for the complaint of batch #s: 7262531 and 7353646 during this production run.

Event Description

It was reported that multiple bd luer-lok¿ syringes were found with particulate matter contamination (45), product damage (43), excess lubricant (1), scale marking issues (212), inclusions (2), and a misaligned gasket (1).

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8206600
• MDR Text Key: 131770645
• Report Number: 1911916-2018-00816
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903010332
• UDI-Public: 382903010332
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301033
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other