MAUDE Adverse Event Report: BARD ACCESS SYSTEMS S/L PERC 7FR 65D; CHRONIC CATHETER

Model Number	7711700
Medical Device Problem Codes	Fracture (1260); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has not been returned to the manufacturer for evaluation, however, a photo was provided.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 7711700 chronic catheter allegedly experienced fracture.This information was received from one source.This event did not involve a patient as there was no patient contact, therefore, patient information was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 7711700 chronic catheter allegedly experienced fracture.This information was received from one source.This event did not involve a patient as there was no patient contact, therefore, patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation, however, a photo was provided for review.The investigation is confirmed for the damaged introducer sheath tip, however it is inconclusive for fracture.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g4, h6 (device).H11: g1, h6 (method, 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.

• Brand Name: S/L PERC 7FR 65D
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9941715
• Report Number: 3006260740-2020-01226
• Device Sequence Number: 2900412
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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: No Information
• Device Model Number: 7711700
• Device Catalogue Number: 7711700
• Device Lot Number: REDS3809
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/10/2020
• Patient Sequence Number: 1