MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE WITH NEEDLE

Catalog Number 928852

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd¿ insulin syringe with needle had a loose plunger rod.No serious injury or medical intervention was reported.

Event Description

It was reported that bd insulin syringe with needle had a loose plunger rod.No serious injury or medical intervention was reported.

Manufacturer Narrative

No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.A review of the device history record was completed for batch # 6347588 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200676262] noted that did not pertain to the complaint.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.

Manufacturer Narrative

Customer returned (2) 3/10cc, 12.7mm, 29g walgreens syringes in an open poly bag from lot # 6347588.Customer states that the plunger rod does not stay in place and has no resistance.Both returned syringes were tested and both plunger rods were exercised in the barrel properly without any observed defects.A review of the device history record was completed for batch # 6347588 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200676262] noted that did not pertain to the complaint.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that bd insulin syringe with needle had a loose plunger rod.No serious injury or medical intervention was reported.

• Brand Name: BD¿ INSULIN SYRINGE WITH NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7974682
• MDR Text Key: 124113347
• Report Number: 1920898-2018-00782
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (y/n): N
• PMA/PMN Number: K941657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 928852
• Device Lot Number: 6347588
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other