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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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: capa not required at this time.
Event or Problem Description
It was reported that needle 26x1/2 rb needle was defective.The following information was provided by the initial reporter: it is reported customer experienced fill resistance.Verbatim: (b)(4).Caller reported that needle was defective.Number of occurrences: 1 time.Did the caller insert the needle into the cartridge and encounter fill resistance? no.Was the syringe/needle reused? no.Did issue cause any injury? no.Did customer require medical intervention? no.Is product available for return to bd? no.Resolution: caller successfully filled a cartridge with insulin.No further follow up is required.Cts to send replacement.

• 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: 12537260
• Report Number: 1911916-2021-01025
• Device Sequence Number: 1414315
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: 08/30/2021
• Initial Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 MO