MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD PERISAFE I¿; EPIDURAL CATHETER KIT

Catalog Number 405066

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2018

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 a bd perisafe i¿ had a hole in the needle chamber.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Dhr for lot number 8030608 was reviewed and no qns or other events were related to the complaint stated by the customer.Material (b)(4) with lot number 8030608 was manufactured on january 31, 2018.According to sampling plan applied for product performance, this lot was accepted.During this lot, 20 samples were tested by leak test and functionality on the luer mold of the needle weiss epidural.This test is performed by qa tech on final inspection of the kit, during this test no values out of specification or hole were found.The needle weiss epidural it is a subassembly that is placed in the kit.During the packaging of this lot, was used the lot number 8008594 of the needle subassembly, this lot was manufactured on january 09, 2018.According to sampling plan applied for product performance, this lot was also accepted.During the manufacture of subassembly of lot 8008594, 258 samples were tested for leak test on the luer mold of the needle weiss epidural.This test is performed by qa tech on molding process of the needle, during this test no values out of specification or hole were found.All relevant information during the dhr review shown that meet all established manufacturing criteria.No sample was provided to perform the testing and investigation of the complaint made by the customer.On the photos provided it is not shown clearly the defect stated by the customer that is why we could not confirm the defect.

Event Description

It was reported that a bd perisafe i had a hole in the needle chamber.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD PERISAFE I¿
• Type of Device: EPIDURAL CATHETER KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7990873
• MDR Text Key: 124670867
• Report Number: 9610847-2018-00344
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/14/2018

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: 01/01/2023
• Device Catalogue Number: 405066
• Device Lot Number: 8030608
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/22/2018
• Supplement Dates Manufacturer Received: 10/01/2018
• Supplement Dates FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other