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

Catalog Number PFS-Y17

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Received one set of connector and catheter connected to filter.The clip was attached to connector, fixed by medical tape, at slightly shifted position.Visual inspection: catheter was crushed at a position of 922mm from tip.Connector was identical to standard sample, and no abnormality was found on latch portion.Clip was identical to standard sample, although the slit is wider, which is considered to be due to usage.Dimension check: the length of catheter was 1017mm, which satisfies spec of 1002.5-1017.5mm.The outer diameter of catheter tip was 0.8551mm, satisfies spec of 0.80-0.88mm.The slit width of the clip was 1.3287mm, satisfies spec of 0.5-1.5mm.Functional test: tensile test with returned connector and unused catheter was conducted.(returned catheter could not be used since disinfection could not be performed due to crush) 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 specified standard.Clip could not be attached securely to the connector for the first three times, but after fourth trial, it could be secured.Production acceptance inspection history: acceptance inspection record of catheter, connector, and clip of the subject batches was examined, and no abnormalities were found.The product design is being updated to increase the force required to open the catheter connector under change control: hc-chc-m-div-1306.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

As reported by the user facility ((b)(4)): the catheter came off from the connector without being locked.

• Brand Name: PERIFIX®
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4842408332
• MDR Report Key: 8667106
• MDR Text Key: 147165677
• Report Number: 9610825-2019-00205
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2019

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: PFS-Y17
• Device Lot Number: 18F22H82YP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2019
• Distributor Facility Aware Date: 06/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/04/2019
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1