MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN 7BAG 420CAS JP

Catalog Number 326666

Device Problem Material Puncture/Hole (1504)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the syringe 0.5ml 29ga 1/2in 7bag 420cas jp experienced the cannula piercing through the shield prior to use.The following information was provided by the initial reporter: the customer found that the shield was melted and the needle was exposed.

Event Description

It was reported that the syringe 0.5ml 29ga 1/2in 7bag 420cas jp experienced the cannula piercing through the shield prior to use.The following information was provided by the initial reporter: the customer found that the shield was melted and the needle was exposed.

Manufacturer Narrative

H.6.Investigation: customer returned (1) loose 1/2cc, 12.7mm syringes.Customer states that the shield was melted and the needle was exposed.The returned syringe was examined and exhibited a damaged shield.However, the cannula was through the shield.Unable to perform dhr check for shield damaged and cannula through shield due to unknown lot number.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (damaged shield).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (cannula through shield).Process summary: automatic syringe assembly machine, which feeds 0.5ml, 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.Dhr, l2l dispatches, logbook entries could not be looked at as no lot number was given.Root cause for this defect cannot be determined.H3 other text : see h.10.

• Brand Name: SYRINGE 0.5ML 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: 10611039
• MDR Text Key: 209636563
• Report Number: 1920898-2020-01334
• 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: 10/08/2020

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 Catalogue Number: 326666
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other