MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SM TI W/ATT 6.6 FR OE AN; CHRONIC CATHETER

Model Number 0606100

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

The lot number of the device was provided.The device history records are currently under review.The return of the sample is pending.The investigation is currently underway.(expiry date:03/2021).

Event Description

It was reported sometime post chronic catheter placement, the device allegedly migrated to the pulmonary artery.The patient's 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: a sample evaluation could not be performed, as the device was not returned.Although a definitive root cause could not be determined, suture damage, cathlock improperly securing catheter, and catheter break could have potentially caused or contributed to the reported event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b2;d4 (expiry date:03/2021); g4; h4 h11: d10, h6 (results, conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported sometime post chronic catheter placement, the device allegedly migrated to the pulmonary artery.The patient's status is unknown.

• Brand Name: SM TI W/ATT 6.6 FR OE AN
• Type of Device: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9187818
• MDR Text Key: 162250547
• Report Number: 3006260740-2019-03023
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026041
• UDI-Public: (01)00801741026041
• Combination Product (y/n): N
• PMA/PMN Number: K050310
• 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: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 0606100
• Device Catalogue Number: 0606100
• Device Lot Number: REAQ0773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention