MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305156
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9163867, medical device expiration date: 2024-08-31, device manufacture date: 2019-06-12, medical device lot #: 8361924, medical device expiration date: 2024-02-29, device manufacture date: 2018-12-27.Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 9163867.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Investigation conclusion: based on the investigation and with no analysis of the sample the symptom reported by the customer could not be confirmed.This lot was produced for 1.9mm units; therefore, the cpm is 0.53.We will continue monitoring this lot and symptom.With no sample analysis a potential root cause could not be offered.(b)(4).
Event or Problem Description
It was reported that 2 needles 22x1-1/2 rb experienced broken needles.The following information was provided by the initial reporter: material no: unknown batch no: 9163867, 8361924.  it was reported that pr package difficult to open resulted in broken injection needles pr package difficult to open - broken injection - needles are very hard to open - per patient.Dose is 2.4 and it only could save w these both times.

• Brand Name: NEEDLE 22X1-1/2 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: 10809533
• Report Number: 1911916-2020-01016
• Device Sequence Number: 14535314
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (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): 10/20/2020

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 Model Number: 305156
• Device Catalogue Number: 305156
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1