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 Problems Fracture (1260); Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2023

Event Type  malfunction  

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 during use with bd perisafe¿ tuohy epidural needle air bubbles occurred and it was discovered that the inlet chamber was broken.A new perisafe was used and there was no report of the patient impact.The following information was provided by the initial reporter, translated from spanish to english: in the epidural catheter placement procedure, i repeatedly showed that i did not lose resistance despite being anatomically in the correct position.I check the equipment, finding bubbling with air administration in the inlet chamber of the tuohy needle, visualizing that it is broken.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue of catheter defective / damaged was not confirmed upon inspection of the photos.During the examination of the photos supplied the defect reported could not be observed.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.Dhr was reviewed for this lot numbers and there are no internal rejects related to the reported issue during this order.According to control plan for the manufacturing process, this lots was accepted and meet acceptance criteria.

Event Description

It was reported that during use with bd perisafe¿ tuohy epidural needle air bubbles occurred and it was discovered that the inlet chamber was broken.A new perisafe was used and there was no report of the patient impact.The following information was provided by the initial reporter, translated from spanish to english: in the epidural catheter placement procedure, i repeatedly showed that i did not lose resistance despite being anatomically in the correct position.I check the equipment, finding bubbling with air administration in the inlet chamber of the tuohy needle, visualizing that it is broken.

• 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 ; 8448235433
• MDR Report Key: 16481390
• MDR Text Key: 310689551
• Report Number: 9610847-2023-00047
• 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: 03/06/2023

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
• Device Operator: Other
• Device Catalogue Number: 405066
• Device Lot Number: 2010975
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/06/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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