MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Model Number 328418

Device Problem Break (1069)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 07/19/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd ultra-fine¿ needle of the bd insulin syringe broke off into the consumer's left hand while attempting an injection in the stomach.The consumer went to emergency room, where the needle was surgically removed.The following information was provided by the initial reporter: "consumer reported, the needle broke off in her left hand when she went to give herself an injection stated, she had already drawn up the insulin, went to put needle in her stomach and somehow, hit her hand with the needle and it broke off into her hand.Stated, went to emergency room and needle was removed surgically from her left hand.State, her hand is now swollen and painful to use.No follow up necessary.Stated, she was told to reach out to primary if she has anymore issue with hand.".

Event Description

It was reported that the bd ultra-fine¿ needle of the bd insulin syringe broke off into the consumer's left hand while attempting an injection in the stomach.The consumer went to emergency room, where the needle was surgically removed.The following information was provided by the initial reporter: "consumer reported, the needle broke off in her left hand when she went to give herself an injection stated, she had already drawn up the insulin, went to put needle in her stomach and somehow, hit her hand with the needle and it broke off into her hand.Stated, went to emergency room and needle was removed surgically from her left hand.State, her hand is now swollen and painful to use.No follow up necessary.Stated, she was told to reach out to primary if she has anymore issue with hand.".

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 8/19/2020.Investigation: customer returned (4) loose 1cc, 8mm syringes.Customer states that she hit her hand with the needle and the needle broke off in her left hand when she went to give herself an injection and her hand is now swollen.All returned syringes were examined and 2 out of 4 samples exhibited a bent cannula.Both remaining samples exhibited a broken cannula.Microscopic examination of the returned samples revealed characteristics such as residual bends on the broken hub end, cracked adhesive and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the adhesive made this observation more apparent.Shields were also examined for any possible scrapes or cuts related by cannula recapping or improper shielding, however nothing was observed.A review of the device history record was completed for batch# 0069107.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200880368, 200880402] noted that did not pertain to the complaint.Root cause: bending/re-straightening mode of failure done by the customer during use of the product.

• Brand Name: BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10388976
• MDR Text Key: 202382804
• Report Number: 1920898-2020-01022
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/03/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: 328418
• Device Catalogue Number: 328418
• Device Lot Number: 0069107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 07/20/2020
• Supplement Dates FDA Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention