MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP

Catalog Number 326631

Device Problem Material Separation (1562)

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

Event Date 07/08/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Date received by manufacturer: bd was initially made aware of this complaint on (b)(6) 2021.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2021-08-09 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that syringe 0.3 ml 29 ga 1/2 in 7 bag 420cas (b)(4) hub separated.The following information was provided by the initial reporter: there was no needle assembled in the product.

Event Description

It was reported that syringe 0.3ml 29ga 1/2in 7bag 420cas jp hub separated.The following information was provided by the initial reporter: there was no needle assembled in the product.

Manufacturer Narrative

H6: investigation summary: no samples were returned therefore the investigation was performed based on the photos provided.Two photos of a 0.3ml bd insulin syringe were provided.The customer reported that there was no needle assembled in the product.Both photos were examined, and it was observed that the needle hub/shield assembly was detached from the barrel.No damage to the barrel tip was observed.Due to the batch being unknown, no dhr review can be completed.Bd was able to duplicate or confirm the customer¿s indicated failure based on the photos received (hub separates).Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Capa (b)(4) has been opened to address this issue h3 other text: see h10.

• Brand Name: SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12316449
• MDR Text Key: 266418355
• Report Number: 1920898-2021-00888
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326631
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1