MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD¿ PERISAFE I ANESTHESIA KIT 16 X 3-1/2IN

Catalog Number 400679

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ perisafe i anesthesia kit 16 x 3-1/2in was missing label information.No serious injury or medical intervention was reported.

Manufacturer Narrative

Dhr for lot number 8008626 was reviewed and no qns or other events were related to the complaint stated by the customer.Material (b)(4) with lot number 8008626 was manufactured on january, 2018.According to sampling plan applied, this lot was accepted without any defect or deviation.During this lot, 125 samples were inspected visually during the final audit without found any defect the inspection is performed by qa tech on final inspection of the kit.The epidural catheter it is received from external supplier during the process only the outside diameter is verified 100% tread assist is installed into epidural catheter, at raw material receipt a random sampling is taken to perform visual inspection by missing marks on the tip formed end, on reported batch the following batches of epidural catheter 115370273mex were used 73f1700294, 73d1700462, 73d1700463, & 73f1700086 all of these lots were received without found any defect at incoming inspection.Manufacturing process was reviewed and no potential failure modes were found.No sample or photos were provided to perform sample evaluation.All relevant information during the dhr review shown that meet all established manufacturing criteria.We could not determine the root cause and cannot confirm the issue stated by the customer due that no samples/photos were sent for evaluation.

Event Description

It was reported that bd perisafe i anesthesia kit 16 x 3-1/2in was missing label information.No serious injury or medical intervention was reported.

• Brand Name: BD¿ PERISAFE I ANESTHESIA KIT 16 X 3-1/2IN
• Type of Device: ANESTHESIA KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8061120
• MDR Text Key: 127075969
• Report Number: 9610847-2018-00391
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2018
• 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: 400679
• Device Lot Number: 8008626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other