MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. PERIFIX CONTINUOUS EPIDURAL CATH 20 GA. CLOSED SOFT TIP; EPIDURAL CATHETER

Model Number CE18TKST

Device Problems Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2014

Event Type  Injury  

Event Description

Ob pt needed emergency c-section due to baby condition deteriorating in utero.Anesthesiologist inserted epidural catheter for anesthesia, but it linked and needed to be removed.Inserted 2nd catheter, but unable to advance so removed that one, but it had a section missing after removal.Inserted 3rd catheter which worked well.Procedure continued with birth of live baby.(b)(6) did well.We scanned to determine if tip of catheter could be see in pt.Catheter is radiopaque and should be seen if present.Not seen.Scanned after 3rd catheter was removed and still not seen.Literature states if not seen, not present.Pt with no unusual six's but was told that occurred.We determined it must have been a defective catheter.Duration of use: 10 min.Diagnosis or reason for use: needed to administer anesthesia emergently to ob pt.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL CATH 20 GA. CLOSED SOFT TIP
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; mason city 50401
• MDR Report Key: 4055904
• MDR Text Key: 19804424
• Report Number: MW5037988
• Device Sequence Number: 2
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CE18TKST
• Device Lot Number: 61370002
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Weight: 113