JACKSON PRATT REF SU13-1309

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-10 for JACKSON PRATT REF SU13-1309 manufactured by Cardinal Health.

Event Text Entries

[28150131] Surgeon removed jackson pratt at bedside. The jackson pratt broke. The jackson pratt was unable to be removed in its entirety at the bedside. The end of the jackson pratt was retained. The physician performed a diagnostic laparoscopy and jackson pratt removal. The end of the jackson pratt drain was found to be in place and was removed completely. The facility had two lots in circulation. We narrowed the broken device down to one fo these two lot numbers 1150304 or 1150306. Device is available for evaluation; however, the retained piece is not available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 5145185
• MDR Report Key: 5145185
• Date Received: 2015-09-10
• Date of Report: 2015-09-09
• Date of Event: 2015-08-29
• Date Facility Aware: 2015-08-29
• Report Date: 2015-09-09
• Date Added to Maude: 2015-10-13
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: JACKSON PRATT
• Generic Name: JP DRAIN
• Product Code: GCD
• Date Received: 2015-09-10
• Model Number: REF SU13-1309
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CARDINAL HEALTH
• Manufacturer Address: WAUKEGAN IL 60085 US 60085

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2015-09-10