MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 30GA 7/8IN BSG CLEAR HUB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	302890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: na.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 9095979.Medical device expiration date: na.Device manufacture date: 05apr2019.Medical device lot #: 0204983.Medical device expiration date: na.Device manufacture date: 22jul2020.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd needle 30ga 7/8in bsg clear hub the needle cannula broke.There was no report of patient impact.The following information was provided by the initial reporter:   it was reported by the consumer broken cannula.- cannula is broken.
Additional Manufacturer Narrative
H6: investigation: it was reported the cannula was broken.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a needle assembly with no packaging blister or plastic shield.The needle has been bent about seventy-five degrees and is out of the plastic needle hub.No other defects or imperfections were observed.A device history record review was completed for provided material number 302890, lot numbers 9095979, 0204983 and 0015341.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.
Event or Problem Description
It was reported while using bd needle 30ga 7/8in bsg clear hub the needle cannula broke.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the consumer broken cannula.Cannula is broken.

• Brand Name: BD NEEDLE 30GA 7/8IN BSG CLEAR HUB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14365375
• Report Number: 1911916-2022-00251
• Device Sequence Number: 5622079
• Product Code: FMI
• UDI-Device Identifier: 00382903028900
• UDI-Public: 00382903028900
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2022

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: 302890
• Device Lot Number: 0015341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown