MAUDE Adverse Event Report: BARD ACCESS SYSTEMS S/L PERC 8FR 65D; CHRONIC CATHETER

Model Number	7726950
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 12/2023).
Event or Problem Description
It was reported that during tunneling, the catheter allegedly broke.There was no reported patient injury.
Event or Problem Description
It was reported that during tunneling, the catheter allegedly broke.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.H10: d1; d2; d4 (catalog # and lot #); d4 (expiry 08/2024); g4; g5.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 or Problem Description
It was reported that during tunneling, the catheter allegedly broke.There was no reported patient injury.
Additional 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: two groshong cv d/l catheter, one catheter segment, one syringe, one guidewire hoop, one peel-apart sheath, one connector, two clear connector locking sleeves, two tunneler, and one unknown guidewire in a hoop.The peel-apart sheath was returned peeled apart and with multiple kinks.The sample appears to have been cut and part of the groshong catheter is missing.One groshong cv d/l catheter was attached to the other tunneler, which was also bent, and a complete circumferential break on both lumens was noted at approximately 21.2cm proximal to the y-body.Blood and residue were noted throughout.The investigation is inconclusive due to the sample being in poor condition.The definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.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.

• Brand Name: S/L PERC 8FR 65D
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9855603
• Report Number: 3006260740-2020-00883
• Device Sequence Number: 16886178
• Product Code: LJS
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7726950
• Device Catalogue Number: 7711800
• Device Lot Number: REDW1403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 04/24/2020; 08/21/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/27/2020; 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 148