MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 26X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd implemented a thorough investigation following our corrective preventative action protocol.This was opened for a trend in reports of ¿needle clogged / blocked¿, ¿aspirate / draw (cannot / difficult)¿, and ¿needle bent¿.All three of these issues have the same net effect: temporary interruption of flow of insulin into the reservoir.Based on the investigation, these issues appear to be related to the use case which involves drawing insulin from a vial into a syringe and then filling the reservoir of the insulin pump via a small port off the body in an iterative process, utilizing existing / ¿off the shelf¿ products rather than a product designed for this use.Bd products are designed to be single use, and because this is an "off the shelf" product, bd specifications do not take into account any requirements specific to the tandem use case.The investigation concludes the complaints are related to the use case and not due to a product nonconformance.
Event or Problem Description
It was reported that needle 26x1/2 rb had a fill resistance issue.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported fill resistance issue.Caller reported fill resistance issue.Number of occurrences - 2 times did the caller insert the needle into the cartridge and encounter fill resistance? - yes was the syringe/needle reused? - no was the cartridge reused/refilled? - no product with issue caller did not have information at time of the call needle lot # - unavailable customer's bg at time of event - 566mg/dl ; between 54-500 mg/dl (3.0-27.7 mmol/l), no further bg questions required.Does insulin come out of the existing needle? ¿ n/a, issue happened in the past.Customer had already changed needle [and/] syringe at time of call.Was caller able to fill the existing cartridge with the second needle? ¿ yes.Resolution ¿ caller successfully loaded existing cartridge with second needle.Cts to send goodwill order of cartridges to replace needle.Is product available for return to bd? ¿caller does not have the syringe/needle information.

• Brand Name: NEEDLE 26X1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 12464490
• Report Number: 1911916-2021-00980
• Device Sequence Number: 14469932
• Product Code: FMI
• UDI-Device Identifier: 00382903051113
• UDI-Public: 00382903051113
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2021

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?: No
• Operator of Device: Other
• Device Catalogue Number: 305111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/13/2021
• 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
• Patient Age: 67 YR