MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PERIFIX; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 4513150

Device Problem Break (1069)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/14/2020

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).We received: no sample, 4 pictures of a used perifix catheter 0.45x0.85, 20g s-o in open packaging.The perifix catheter on the picture is shorn off.The shorn off area is slanted and shows a smooth structure.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off." we exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.The complaint is not confirmed.Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b.Braun medical, inc.If the sample and or additional pertinent information becomes available, a follow up report will be submitted.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): catheter broke when removing.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).A review of the batch and manufacturing records revealed no abnormalities or nonconformities.We received: no sample, 4 pictures of a used perifix catheter 0.45x0.85, 20g s-o in open packaging.The perifix catheter on the picture is shorn off.The shorn off area is slanted and shows a smooth structure.Such damages may occur when the catheter will be withdrawn against the cannula bevel and thereby shear off.Please see instructions for use: "never pull the catheter through the needle as it may otherwise shear off." we exclude a manufacturing fault since the catheters were taken to a 100% examination and therefore no mechanical damages or manufacturing faults are allowed.The complaint is not confirmed.

• Brand Name: PERIFIX
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 10183620
• MDR Text Key: 198864446
• Report Number: 9610825-2020-00121
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/27/2020

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: Health Professional
• Device Catalogue Number: 4513150
• Device Lot Number: 19L21A8701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 05/25/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1