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

Catalog Number PFS-S18

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received perifix soft tip,straight,bulk,g20 [1].The following investigations were conducted: visual inspection: the catheter was tied in a knot, otherwise no abnormalities were found.Functional inspection: catheter tensile strength test.Conducted using received connector and received catheter.Specifications: above 11n.Received sample: 13.22n.Sample was within specifications.Connection check: received catheter was able to be inserted into received connector without resistance and up to the marking point.Physical inspection: catheter length test.Specifications: 959.5mm ~ 1060.5mm.Received sample: 1026.0mm.Unused reference sample: 1043.0mm.Sample was within specifications.Catheter outer diameter (end of catheter) specifications: 0.84mm ~ 0.90mm.Received sample: 0.852.Sample was within specifications.Summary and assessment: based on the conducted investigations the catheter is within the specification.Although the product met the specifications, the product design is being updated to increase the force required to open the catheter connector under change control: hc-(b)(4).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)(6)): event 2: catheter withdrawal.

• 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: 9131833
• MDR Text Key: 160449630
• Report Number: 9610825-2019-00441
• 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: 09/27/2019

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-S18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2019
• Initial Date FDA Received: 09/27/2019
• 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