MAUDE Adverse Event Report: BD CARIBE LTD. BD NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE; ANESTHESIA CONDUCTION NEEDLE

Model Number	405138
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: unknown; additional contact phone # was provided: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle pulled out during use and remained in injection site resulting in surgery to remove with a bd needle sp s/su 25ga tw 3-1/2in whitacre.The following information was provided by the initial reporter: it was reported the needle sheared off in a patient's back resulting in the patient having surgery to get it removed.
Event or Problem Description
It was reported that the needle pulled out during use and remained in injection site resulting in surgery to remove with a bd needle sp s/su 25ga tw 3-1/2in whitacre.The following information was provided by the initial reporter: it was reported the needle sheared off in a patient's back resulting in the patient having surgery to get it removed.
Additional Manufacturer Narrative
Investigation: bd has not been provided with photos or samples for catalog 405138 lot 8058777 to investigate for this record.Unfortunately, as a result, bd was unable to verify the reported issue or determine a definitive root cause.Device history record review for the lot numbers impacted was performed and no non-conformance's impacting potential low pull or cannula pull out of hub were observed.All the inspections were performed as established per procedures with satisfactory results.Thus, preventive maintenance and instrument calibrations were in compliance.

• Brand Name: BD NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9751329
• Report Number: 2618282-2020-00010
• Device Sequence Number: 727554
• Product Code: BSP
• UDI-Device Identifier: 30382904051380
• UDI-Public: 30382904051380
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 405138
• Device Catalogue Number: 405138
• Device Lot Number: 8058777
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/25/2020
• Supplement Report FDA Received Date: 04/21/2020
• 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