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

Catalog Number 301031

Device Problems Device Markings/Labelling Problem (2911); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7227709, medical device expiration date: 2022-08-31, device manufacture date: 2017-08-15.Medical device lot #: 7353627, medical device expiration date: 2022-12-31, device manufacture date: 2017-12-19.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 luer-lok¿ syringes had issues with scale marking errors, foreign contaminates, and damaged syringes.

Manufacturer Narrative

Describe event or problem: it was reported that the bd luer-lok¿ syringes had issues with scale marking errors, foreign contaminates, inclusions and damaged syringes.There were two lot numbers involved.For lot # 7227709 there were 45 occurrences of scale marking issue, 5 occurrences of foreign matter, and 16 occurrences of inclusions.For lot # 7353627 there were 85 occurrences of scale marking issue, 59 occurrences of foreign matter, and 64 occurrences of inclusions.There was no report of injury or medical intervention.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review was completed with the following results: 7557709: 24 inspections performed - 1 rejection for missing print / ink rings (root cause - hose broke to ink pump twice / corrective action - replaced hose to ink pump twice).7353627: 25 inspections performed - no defects recorded or issues reported.No quality notifications issued.Root cause description: no root cause can be determined as no samples were received.

Event Description

It was reported that the bd luer-lok¿ syringes had issues with scale marking errors, foreign contaminates and inclusions there were two lot numbers involved.For lot # 7227709 there were 45 occurrences of scale marking issue, 5 occurrences of foreign matter, and 16 occurrences of inclusions.For lot # 7353627 there were 85 occurrences of scale marking issue, 59 occurrences of foreign matter, and 64 occurrences of inclusions.There was no report of injury or medical intervention.

• 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: 8204639
• MDR Text Key: 131722590
• Report Number: 1911916-2018-00812
• Device Sequence Number: 1
• Product Code: FMF
• 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: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301031
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other