PERIFIX SOFT TIP N/A PCK-925J

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 2019-03-07 for PERIFIX SOFT TIP N/A PCK-925J manufactured by B. Braun Melsungen Ag.

Event Text Entries

[140149549] (b)(4). Note: this report is being filed for an item number that is not sold in the united states, however this item or similar items are sold in the united sates by b. Braun medical, inc. We received a used catheter and guide. The vicinity of the tip marking of the catheter was broken. The broken of catheter side was not returned. Investigation result. Visual inspection: the catheter is broken 14mm away from tip. The surface of the catheter had scratched marks. Others: when observing the tearing surface in magnification, it was confirmed that there was a trace like rubbing against something. It is similar to the shape of a reference image we assume a problem during application process. Justification: this complaint is not confirmed. Note: this report is being filed as both a product problem and an adverse event due to the fact that the tip of the catheter may have remained in the patient. No intervention was done, and currently there is no serious injury to the patient, so this report has been classified only as a malfunction. The batch record could not be reviewed since the lot number is unknown.
Patient Sequence No: 1, Text Type: N, H10

[140149550] As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): damaged catheter tip. Staff felt resistance to a catheter when they tried to apply epidural anesthesia. The catheter tip was damaged when they removed it along with a cannula from the patient. There is possibility that fragments still remain in the patient body.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610825-2019-00035
• MDR Report Key: 8400416
• Report Source: FOREIGN,HEALTH PROFESSIONAL
• Date Received: 2019-03-07
• Date of Report: 2019-03-07
• Date of Event: 2019-02-08
• Date Facility Aware: 2019-03-07
• Report Date: 2019-03-07
• Date Reported to FDA: 2019-03-07
• Date Reported to Mfgr: 2019-03-07
• Date Mfgr Received: 2019-02-12
• Date Added to Maude: 2019-03-07
• 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: 901 MARCON BLVD.
• Manufacturer City: ALLENTOWN 18109
• Manufacturer Country: US
• Manufacturer Postal: 18109
• Manufacturer Phone: 4847197287
• 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: 2019-03-07
• Returned To Mfg: 2019-02-27
• Model Number: N/A
• Catalog Number: PCK-925J
• Lot Number: UNKNOWN
• 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, HESSEN 34212 GM 34212

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2019-03-07