MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OPTIDRAIN, LOCK PIGTAIL, 8FR X 30CM; DRAINAGE CATHETER

Catalog Number NOD8LPT

Device Problem Break (1069)

Patient Problem Injury (2348)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 07/2021).

Event Description

It was reported that post drainage catheter placement the tube allegedly broke.Reportedly, surgery was required to remove the tube fragments.The current patient status is unknown.

Event Description

It was reported that post drainage catheter placement the tube allegedly broke.Reportedly, surgery was required to remove the tube fragments.The current patient status is unknown.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for catheter break, as the photo shows several lengths of tubing of a greenish color, many with extensive amounts of residue that appears to be blood or other biological material.The nature of the breaks between segments are not easily visible, but in general appear to be ragged/uneven.The nylon thread is not visible, nor the rest of the catheter.Although a definitive root cause could not be determined, catheter placement for excessive periods, pulling roughly on the catheter, or material weakness could have potentially caused or contributed to the reported event.Labeling review: as the root cause of the complaint is unknown, the applicability of any particular labeling is unknown.Therefore, product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) are considered adequate at this time.

• Brand Name: OPTIDRAIN, LOCK PIGTAIL, 8FR X 30CM
• Type of Device: DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8608112
• MDR Text Key: 144976240
• Report Number: 3006260740-2019-01372
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741037092
• UDI-Public: (01)00801741037092
• Combination Product (y/n): N
• PMA/PMN Number: K951475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NOD8LPT
• Device Lot Number: GFCT3361
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR