PERIFIX SOFT TIP N/A 4512006C

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-06-19 for PERIFIX SOFT TIP N/A 4512006C manufactured by B. Braun Melsungen Ag.

MAUDE Entry Details

• Report Number: 9610825-2019-00225
• MDR Report Key: 8712484
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-06-19
• Date of Report: 2019-07-02
• Date of Event: 2019-05-07
• Report Date: 2019-07-02
• Date Reported to FDA: 2019-07-02
• Date Reported to Mfgr: 2019-07-02
• Date Mfgr Received: 2019-05-23
• Device Manufacturer Date: 2018-09-26
• Date Added to Maude: 2019-06-19
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JONATHAN SEVERINO
• Manufacturer Street: 861 MARCON BOULEVARD
• Manufacturer City: ALLENTOWN PA 18109
• Manufacturer Country: US
• Manufacturer Postal: 18109
• Manufacturer Phone: 4842408332
• Manufacturer G1: B. BRAUN MELSUNGEN AG
• Manufacturer Street: CARL-BRAUN-STR. 1
• Manufacturer City: MELSUNGEN, 34212
• Manufacturer Country: GM
• Manufacturer Postal Code: 34212
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PERIFIX SOFT TIP
• Generic Name: EPIDURAL CATHETER
• Product Code: DQR
• Date Received: 2019-06-19
• Model Number: N/A
• Catalog Number: 4512006C
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 9 MO
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: B. BRAUN MELSUNGEN AG
• Manufacturer Address: CARL-BRAUN-STR. 1 MELSUNGEN, 34212 GM 34212

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-19