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

Catalog Number	928852
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that bd¿ insulin syringe with needle had a loose plunger rod.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd insulin syringe with needle had a loose plunger rod.No serious injury or medical intervention was reported.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7974682
• Report Number: 1920898-2018-00782
• Device Sequence Number: 13710536
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 928852
• Device Lot Number: 6347588
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018; 09/27/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 10/23/2018; 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other