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

Catalog Number 928857

Device Problems Break (1069); Loose or Intermittent Connection (1371); Contamination /Decontamination Problem (2895)

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

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that there was a bd insulin syringe with bd ultra-fine¿ needle with sterile breach due to a broken shield that was no longer connected to the device.The needle was also found bent and separated from the device.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary:customer returned (1) 1/2cc, 8mm, 31g walgreens syringe in an open poly bag from lot # 7296788.Customer states that the shield was missing, the needle was bent, the shield was broken, and the needle was found in the bottom of the bag.The syringe was examined and exhibited a broken shield and a bent cannula.No missing shield or separated cannula was observed on the returned sample.A review of the device history record was completed for batch# 7296788.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200724502] noted for no shield.There were five (5) notifications [200724475, 200724479, 200724476, 200724452, 200721796] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent cannula, broken shield).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (needle separates, missing shield).Investigation conclusion: possible root cause: likely a jaw jam of form fill & seal which bent the cannula and then made it to packaging.Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacturer: yes.

Event Description

It was reported that there was a bd insulin syringe with bd ultra-fine¿ needle with sterile breach due to a broken shield that was no longer connected to the device.The needle was also found bent and separated from the device.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7744903
• MDR Text Key: 116053248
• Report Number: 1920898-2018-00615
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 928857
• Device Lot Number: 7296788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Date Manufacturer Received: 07/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other