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

Catalog Number 4513800

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as event 1 of b.Braun melsungen ag internal report # (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.We received three used perifix catheter connector without packaging, one used perifix catheter connector in open packaging and one perifix catheter connector in original closed packaging.The following investigations were conducted: visual inspection: the received samples were taken to a visual inspection.The catheter connectors were handed over by the customer in open condition.No damages or deviations were detected at the catheter connectors.Functional inspection: the samples were taken to functional tests according to the test plan.Nominal: it must be possible to push the catheter easily into the catheter connector.Actual: it was easily possible to push the catheter into the catheter connector.Function faults were not detected.Nominal: the catheter connector must be opened and closed 5 times with inserted catheter.Actual: the catheter connectors can be opened and closed 5 times with inserted catheter without any difficulties.A self-opening of the catheter connectors, as described by the customer, or other function faults were not detected.The function test was repeated over a period of 2 hrs (catheter connector 2 hrs in closed condition).Even after a time of 2 hrs a self-opening of the catheter connectors was not detected.Nominal: closing catheter lid: closing the catheter lid which engages with a clear click.Actual: a clear click was hearable during closing the catheter lids.Physical inspection: the received catheter connectors and a perifix catheter were taken to a tensile test according to the test plan.Nominal: min.11 n.Actual: 8,17 n - 10,05 n.The tensile strength is not within the specification.Summary and assessment: the defect is due to a development error and already known.Therefore, this complaint is considered as confirmed.The product design is being updated to increase the force required to open the catheter connector under change control: hc-chc-m-div-1306.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): event 1.Catheter disconnection.

• 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: 9126520
• MDR Text Key: 198593609
• Report Number: 9610825-2019-00431
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2024
• Device Catalogue Number: 4513800
• Device Lot Number: 19D25A8701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2019
• 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