MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD PERISAFE¿ TUOHY EPIDURAL NEEDLE; ANESTHETIC CONDUCTION NEEDLE

Catalog Number 405066

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/05/2022

Event Type  Injury  

Manufacturer Narrative

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 bd perisafe¿ tuohy epidural needle broke off in the patient, and additional medical procedures were needed to remove the broken piece.No further information was provided.The following information was provided by the initial reporter, translated from spanish: "device presents rupture approximately 10 cm.On (b)(6) an adverse event occurred with continuous epidural anesthesia device, the event occurred during placement into patient procedure, which it advanced with difficulty, and then it was attempted to be withdrawn, presents rupture in 10 cm approximately.The health professional allegedly reports the distal end was not found, so then it was needed additional procedures to remove the broken part of the device.

Manufacturer Narrative

Our quality engineer inspected the 6 photos submitted for evaluation.The reported issue of guidewire sheared / broke was confirmed upon inspection of the photos.However, bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr for this lot was reviewed and there are no internal rejects related to the reported issue.H3 other text : see h10.

Event Description

It was reported that the bd perisafe¿ tuohy epidural needle broke off in the patient, and additional medical procedures were needed to remove the broken piece.No further information was provided.The following information was provided by the initial reporter, translated from spanish: "device presents rupture approximately 10 cm.On june 05 an adverse event occurred with continuous epidural anesthesia device, the event occurred during placement into patient procedure, which it advanced with difficulty, and then it was attempted to be withdrawn, presents rupture in 10 cm approximately.The health professional allegedly reports the distal end was not found, so then it was needed additional procedures to remove the broken part of the device.

• Brand Name: BD PERISAFE¿ TUOHY EPIDURAL NEEDLE
• Type of Device: ANESTHETIC CONDUCTION NEEDLE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15482095
• MDR Text Key: 300580833
• Report Number: 9610847-2022-00365
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904050665
• UDI-Public: (01)00382904050665
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K211085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405066
• Device Lot Number: 1207453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention