MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31G 8MM; PISTON SYRINGE

Catalog Number 328438

Device Problem Material Separation (1562)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary : exec summary - samples were received and an investigation was performed.This is the 2nd related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.A samples returned - customer returned (1) 0.3ml bd insulin syringe from lot# 0114506.The consumer reported found 1 syringe needle hub removed with needle shield.The returned syringe was examined and it was observed that the needle hub/shield assembly was detached from the barrel.No damage to the barrel tip was observed.Manufacturing ((b)(4)) will be notified of the observed issue.The investigation concluded: confirmed - bd was able to duplicate or confirm the customer¿s indicated failure.Capa/sa - capa (b)(4) has been opened to address this issue.Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.

Event Description

It was reported that 1 bd syringe 0.3ml 31g 8mm hub separated from the device.The following information was provided by the initial reporter : the consumer reported 1 syringe needle hub removed with the needle shield.Date of event : (b)(6) 2021.Sample status : awaiting sample.

• Brand Name: SYRINGE 0.3ML 31G 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12340185
• MDR Text Key: 267239801
• Report Number: 1920898-2021-00910
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328438
• Device Lot Number: 0114506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2020
• 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