MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 6 FR D/L POWERPICC BASIC TRAY W/70 CM GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu3819 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the introducer cannot be smoothly inserted into the blood vessel, and after removal, the end bifurcation is unusable.
Event or Problem Description
It was reported that the introducer cannot be smoothly inserted into the blood vessel, and after removal, the end bifurcation is unusable.
Additional Manufacturer Narrative
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.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficult introducer insertion was inconclusive due to the condition of the returned sample.The product returned for evaluation was one 6fr d/l rad powerpicc catheter tray.The tray was received opened.Blood residue was observed on the tray and various kit components.The microintroducer sheath was peeled.The peel surface and the distal tip of the sheath appeared smooth and unremarkable.The dilator was not returned for evaluation.Microscopic inspection of the sheath revealed a well-formed tip transition.The interface between the catheter and the peeled sheath segments appeared unremarkable.The dilator id was measured and found to be within manufacturing specifications.While no defect or deformity was found during evaluation of the returned sample, the introducer dilator was not returned for evaluation, preventing complete evaluation of the introducer system.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of redu3819 showed no other similar product complaint(s) from this lot number.

• Brand Name: 6 FR D/L POWERPICC BASIC TRAY W/70 CM GUIDEWIRE
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10134644
• Report Number: 3006260740-2020-02005
• Device Sequence Number: 14051546
• Product Code: LJS
• UDI-Device Identifier: 00801741028014
• UDI-Public: (01)00801741028014
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 3276155
• Device Lot Number: REDU3819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1