MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT POWERPICC 4F SL 3CG; 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	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of regq1683 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (regq1683) have been reported from the same facility.
Event or Problem Description
It was reported by the customer that "there was a 'mushroom' on picc introducer.Unable to place introducer." additional information received february 15, 2023: "there was no harm caused to the patient.Picc line was being placed for long term antibiotic therapy.As i attempted to advance introducer after skin was nicked, there was no advancement.I took it off the wire and inspected it and noticed there was a small lip/burr on the gray portion.I had to obtain another introducer to complete the picc.".
Event or Problem Description
It was reported by the customer that "there was a 'mushroom' on picc introducer.Unable to place introducer." additional information received february 15, 2023: "there was no harm caused to the patient.Picc line was being placed for long term antibiotic therapy.As i attempted to advance introducer after skin was nicked, there was no advancement.I took it off the wire and inspected it and noticed there was a small lip/burr on the gray portion.I had to obtain another introducer to complete the picc.".
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: sample (if available), patient severity, applicable previous investigation(s), complaint and lot history review, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged microintroducer sheath is confirmed.One 4.5 fr x 7 cm microintroducer was returned for evaluation.An initial visual observation showed use residue on the returned sample.The distal tip of the sheath was observed to be damaged, and the dilator was observed to be bent where the distal tip of the sheath was positioned over it.A microscopic observation revealed the edges of the distal tip of the sheath were buckled and plastically deformed in multiple locations.No splits or tearing was observed in the sheath material, and no damage was observed on the distal tip of the dilator.The location and shape of the damage observed on the sheath tip and dilator as well as the usage residue observed on and within the returned sample suggest the microintroducer was damaged during use.Possible contributing factors include insertion angle, excessive force, and patient anatomy.

• Brand Name: DOT POWERPICC 4F SL 3CG
• 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: 16479236
• Report Number: 3006260740-2023-00647
• Device Sequence Number: 16943681
• Product Code: LJS
• UDI-Device Identifier: 00801741126765
• UDI-Public: (01)00801741126765
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 04/24/2023

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 Model Number: N/A
• Device Catalogue Number: CK000631
• Device Lot Number: REGQ1683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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