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

Model Number 405138

Device Problem Leak/Splash (1354)

Patient Problem Tissue Damage (2104)

Event Date 02/03/2020

Event Type  Injury  

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 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 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.

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
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 9751329
• MDR Text Key: 182211443
• Report Number: 2618282-2020-00010
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051380
• UDI-Public: 30382904051380
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other