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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: the customer provided lot numbers 201021 and 9226367.These do not match the catalog number provided.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Root cause description: based on the limited investigation results, a cause for the reported incident could not be determined.Rationale: 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.Capa # (b)(4).
Event or Problem Description
It was reported that needle 26x1/2 rb broke.This occurred on 2 occasions.The following information was provided by the initial reporter: it is reported customer experienced fill resistance and in another instance the needle broke while attempting to draw insulin.

• 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: 12264201
• Report Number: 1911916-2021-00779
• Device Sequence Number: 3635991
• Product Code: FMI
• UDI-Device Identifier: 00382903051113
• UDI-Public: 00382903051113
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/06/2021
• Initial Report FDA Received Date: 08/02/2021
• 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: 85 YR