MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

Catalog Number 326638

Device Problem Leak/Splash (1354)

Patient Problem Inadequate Osseointegration (2646)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 0.3ml 30ga 8mm 7bag 420cas jp hub separated before use.The following information was provided by the initial reporter: the hub-needle/shield (orange) assembly was separated from the barrel.

Event Description

It was reported that syringe 0.3ml 30ga 8mm 7bag 420cas jp hub separated before use.The following information was provided by the initial reporter: the hub-needle / shield (orange) assembly was separated from the barrel.

Manufacturer Narrative

H.6.Investigation: no samples were returned as of 20 november 2020, therefore the investigation was performed based on the photos provided.Two photos of a (1) loose 0.3ml bd insulin syringe were provided.Consumer reported the hub-needle / shield (orange) assembly was separated from the barrel.The provided photos were reviewed, and it was observed that the syringe exhibited a separated needle hub / shield assembly; no damage to the barrel tip was observed.Unable to perform a dhr review due to an unknown lot number for needle hub separates.Process summary: automatic syringe assembly machine, which feeds 0.3ml, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger / stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Root cause: maintenance dispatch was opened for raised hubs.A couple of plunger heads were stuck in the carrier causing a reduce amount of pressure applied when attaching the needle assembly to the barrel.

• Brand Name: SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10709407
• MDR Text Key: 215339263
• Report Number: 1920898-2020-01439
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326638
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other