MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, PROBE COVER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of regv3258 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the pediatric picc nurse "issues with inserting the introducer.The introducer would buckle and then noticed that there was a break in between the white and gray part.It was almost like the gray sheath was falling apart as they inserted.No harm to patient but this required them having to drop a second introducer on their sterile field.".
Event or Problem Description
It was reported by the pediatric picc nurse "issues with inserting the introducer.The introducer would buckle and then noticed that there was a break in between the white and gray part.It was almost like the gray sheath was falling apart as they inserted.No harm to patient but this required them having to drop a second introducer on their sterile field.".
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, complaint and lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a microintroducer buckling is confirmed and was determined to be manufacturing related.One 3.5 fr microintroducer was returned for evaluation.An initial visual observation showed use residues on the returned microintroducer, and it appeared that the distal end of the gray sheath where it transitions to the dilator was deformed.A microscopic observation revealed deformation on the distal end of the gray sheath, as buckling of the sheath appears to have occurred.The distal tip of the gray sheath appeared to have an abrupt transition in the areas that did not appear to buckle, rather than a smooth transition from the tipping process as it was compared against a non-complainant device.The complaint of a defective microintroducer sheath is confirmed and was determined to be related to manufacturing.The investigation was forwarded to the end-item/manufacturing facility for further evaluation, and bd is working closely with the supplier/manufacturing facility to prevent recurrence of the reported event.

• Brand Name: POWERPICC PROVENA 3F SL MBPLUS (3CG, BIOPATCH, PROBE COVER)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16274315
• Report Number: 3006260740-2023-00288
• Device Sequence Number: 6033469
• Product Code: LJS
• UDI-Device Identifier: 00801741155031
• UDI-Public: (01)00801741155031
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: S1173108D4
• Device Lot Number: REGV3258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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