MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD EPILOR¿ PLASTIC LOR SYRINGE; ANESTHESIA CONDUCTION KIT

Catalog Number 405198

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

It was reported that there was no resistance with the bd epilor¿ plastic lor syringe.The following information was provided by the initial reporter: there was no resistance making it difficult for doctor to find the epidural space.

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: our quality engineer inspected the 14 samples submitted for evaluation.The reported issue of insertion difficult was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that all 14 samples were found to be within proper manufacturing specifications.Functional testing was performed, and no issues were found with the samples.Bd cannot determine the cause of the failure since the defect was not confirmed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch was in compliance with our product specification requirements.H3 other text : see h.10.

Event Description

It was reported that there was no resistance with the bd epilor¿ plastic lor syringe.The following information was provided by the initial reporter: there was no resistance making it difficult for doctor to find the epidural space.

Manufacturer Narrative

Two lots were initially reported for this complaint, however, only 1 was reported.Please see the correct information below for this complaint: d4: medical device lot #: 1033079.D4: medical device expiration date: 31-jan-2026.H4: device manufacture date: 02-feb-2021.D4: medical device lot #: 1006844.D4: medical device expiration date: 31-dec-2025.H4: device manufacture date: 06-jan-2021.H6: investigation summary: our quality engineer inspected the 14 samples submitted for evaluation.The reported issue of insertion difficult was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that all 14 samples were found to be within proper manufacturing specifications.Functional testing was performed, and no issues were found with the samples.Bd cannot determine the cause of the failure since the defect was not confirmed.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and batch 1033079 and 1006844 were in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.

Event Description

It was reported that there was no resistance with the bd epilor¿ plastic lor syringe.The following information was provided by the initial reporter: there was no resistance making it difficult for doctor to find the epidural space.

• Brand Name: BD EPILOR¿ PLASTIC LOR SYRINGE
• Type of Device: ANESTHESIA CONDUCTION KIT
• 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: 15245767
• MDR Text Key: 305422723
• Report Number: 9610847-2022-00312
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405198
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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