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

Catalog Number PFK-Y1800GSC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.Without the actual sample (or device), a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.A review of the batch and manufacturing records revealed no abnormalities or nonconformities.The product design is being updated to increase the force required to open the catheter connector under change control: (b)(4).Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

(b)(4).The catheter came off from the connector.

Manufacturer Narrative

Exemption number e2016018.B.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun melsungen ag internal report # (b)(4).Received a set of catheter, connector, filter and pump made by other company.Visual inspection: catheter was not connected to the connector.Connector cover was locked.Slight damage/deformation was observed on the catheter, at a position of 1001mm from the tip.No abnormality was observed on the connector.Dimension check: the length of catheter was 1011mm, which satisfies spec of 1002.5-1017.5mm.The outer diameter of catheter tip was 0.8652mm, satisfies spec of 0.80-0.88mm.Functional test: tensile test with returned connector and catheter was conducted.The measured tensile strength was 9.4n which satisfies spec of >5.5n.When catheter was inserted to the connector, catheter was smoothly inserted up to the target position, and the cover of connector was locked securely.The insertion depth is confirmed to satisfy standard.Although the returned device met specifications, the product design is being updated to increase the force required to open the catheter connector under change control: (b)(4).Note: b.Braun is aware that the listed exemption has been withdrawn, however since the initial mdr report was filed under this exemption, the follow up is also being filed under the exemption.

• 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: 8667108
• MDR Text Key: 147652077
• Report Number: 9610825-2019-00213
• 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: 11/07/2019

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: PFK-Y1800GSC
• Device Lot Number: 19B05H82YN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2019
• Distributor Facility Aware Date: 06/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2019
• Initial Date Manufacturer Received: 05/17/2019
• Initial Date FDA Received: 06/04/2019
• Supplement Dates Manufacturer Received: 05/17/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1