MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 60 ML LL BNS; PISTON SYRINGE

Catalog Number 301035

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Initial reporter phone #: (b)(6).Investigation summary: based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Molding process.The shrink void resin occurs during the injection molding process and its shown opposite to the side where the fill gate is.It could be possible that there was a variation of the pack pressure inducing this symptom and not detected in the next processes.Frequency of inspections was increased to mitigate these escapes.

Event Description

It was reported while using bd syringe 60 ml ll bns foreign matter was found in the fluid pathway.This occurred 6 times.The following information was provided by the initial reporter, translated from dutch to english: we found an abnormality on the syringe during packing that we have not seen before.It is white matter located in front of the stopper.The matter appears to be embedded.

• Brand Name: BD SYRINGE 60 ML LL BNS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15193881
• MDR Text Key: 304890499
• Report Number: 1911916-2022-00415
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301035
• Device Lot Number: 0303684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1