MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM; 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	04/05/2021
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 reew1776 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reew1776) have been reported from the same facility.
Event or Problem Description
It was reported the microintroducer frayed when attempted to advance it to the vein.A new kit was opened to get another microintroducer.
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged introducer was confirmed, but the exact cause could not be determined.One photo sample of a microez microintroducer was provided for evaluation.Blood residue is present within the distal dilator tip.A section of the distal tip of the dilator sheath appears to be damaged and peeled back.The characteristics of the damaged surfaces could not be clearly inspected from the image provided.Based on the description of the reported event and photo provided, possible contributing factors include insertion technique and forceful advancement during insertion.The product instructions for use (ifu) states, "advance the small sheath and dilator together as a unit over the guidewire, using a slight rotational motion.If necessary, a small incision may be made adjacent to the guidewire to facilitate insertion of the sheath and dilator.Verify institutional guidelines concerning the use of a scalpel prior to making incision." h3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported the microintroducer frayed when attempted to advance it to the vein.A new kit was opened to get another microintroducer.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM
• 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
• MDR Report Key: 11749480
• Report Number: 3006260740-2021-01593
• Device Sequence Number: 17107778
• Product Code: LJS
• UDI-Device Identifier: 00801741034442
• UDI-Public: (01)00801741034442
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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: 1174108
• Device Lot Number: REEW1776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other