MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 31GA 6MM; PISTON SYRINGE

Catalog Number 324911

Device Problem Material Separation (1562)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The customer's address is unknown.New jersey (nj), usa has been used as a default.Investigation summary : exec summary - samples were received and an investigation was performed based only on the photos provided.This is the 1st related complaint for needle hub separates on the reported lot number.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Samples returned - no physical sample device returned.Photos - three photos of a 0.5ml bd insulin syringe were provided.The consumer reported owing to wrong needle assembly, experienced a needle stick.The photos were examined and it was observed that the needle hub and shield assembly was not fully seated on the barrel tip and the cannula was pierced through the shield.No damage to the barrel tip was observed in the photos where the hub assembly is detached from the barrel of the syringe.The exposed cannula could have led to a needle stick.Manufacturing (holdrege) will be notified of the observed issues.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 0.5ml 31ga 6mm hub separated from the device.The following information was provided by the initial reporter :   it was reported by the consumer that owing to a wrong needle assembly the consumer experienced a needle stick.

• Brand Name: BD SYRINGE 0.5ML 31GA 6MM
• 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: 12454513
• MDR Text Key: 271063228
• Report Number: 1920898-2021-00981
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• 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: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 324911
• Device Lot Number: 8274826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/14/2021
• Initial Date FDA Received: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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