MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROVPPSOLO 4FDL MBP; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	S1294108D5
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that microintroducer from a picc that when a coworker was attempting to insert into pts vein was not able to advance.After removed i looked at it and noticed the end of the external sheath was not smooth.Not sure if was like that prior to inserting attempt or not.No injury to patient.No other information provided, at this time.
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that microintroducer from a picc that when a coworker was attempting to insert into pts vein was not able to advance.After removed i looked at it and noticed the end of the external sheath was not smooth.Not sure if was like that prior to inserting attempt or not.No injury to patient.No other information provided, at this time.
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 complaint of a damaged sheath is confirmed; however, the root cause could not be determined.The product returned for evaluation was a 4.5fr microintroducer.Light use residue was observed on the sample.Microscopic inspection of the distal end of the sheath revealed regions of the sheath were buckled and flared outward.The sheath tip deformation was consistent with attempted insertion against resistance.Such resistance may occur if insertion is attempted at a steep angle, if the insertion hole is too small, and if the transition between the sheath and the dilator is rough or abrupt.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: DOT PROVPPSOLO 4FDL MBP
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20514047
• Report Number: 3006260740-2024-06142
• Device Sequence Number: 7204350
• Product Code: LJS
• UDI-Device Identifier: 00801741155208
• UDI-Public: (01)00801741155208(11)240701(17)250630(10)REJR2125
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 06/30/2025
• Device Catalogue Number: S1294108D5
• Device Lot Number: REJR2125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown