PENCAN N/A 4502052N-01

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 2019-11-13 for PENCAN N/A 4502052N-01 manufactured by B. Braun Melsungen Ag.

MAUDE Entry Details

• Report Number: 9610825-2019-00524
• MDR Report Key: 9315222
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-11-13
• Date of Report: 2019-11-13
• Date Mfgr Received: 2019-10-25
• Device Manufacturer Date: 2017-12-06
• Date Added to Maude: 2019-11-13
• 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: PENCAN
• Generic Name: NEEDLE, SPINAL, SHORT TERM
• Product Code: MIA
• Date Received: 2019-11-13
• Returned To Mfg: 2019-11-08
• Model Number: N/A
• Catalog Number: 4502052N-01
• Lot Number: 17N06H8B22
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• 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	1. Required No Informationntervention	2019-11-13