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

Catalog Number	928851
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd ultra-fine¿ needle had 10 syringes that had bent needles and some of the needles had foreign matter on the needle.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd insulin syringe with bd ultra-fine¿ needle had 10 syringes that had bent needles and some of the needles had foreign matter on the needle.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
H.6.Investigation summary: customer returned (5) 1/2cc, 12.7mm, 29g walgreens syringes in an open poly bag from lot # 8057906.Customer states that there is something on the needle.All returned syringes were examined and no foreign matter was observed on any of the samples.A review of the device history record was completed for batch# 8057906.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications (b)(4) noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (foreign matter).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8336160
• Report Number: 1920898-2019-00149
• Device Sequence Number: 139947
• Product Code: FMF
• UDI-Device Identifier: 00311917014890
• UDI-Public: 00311917014890
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 03/31/2023
• Device Catalogue Number: 928851
• Device Lot Number: 8057906
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/01/2019
• 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