MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

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 evaluate.Results are expected soon.A lot history review (lhr) of rees1267 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported the tip (gray part) of the dilator in the kit seemed soft that it teared while advancing through the skin.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.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 from the photograph that was provided for investigation.The photo showed on microintroducer in a clear bag.Deformation was observed at the distal end of the introducer sheath.The material flared outward away from the external surface of the dilator tip.The sheath had not been split.The label with part number 1194108d4 and lot #rees1267 were observed in the photo.Since the reported damage was observed in the provided photo, the complaint was confirmed, but the exact mechanism of damage could not be determined.

Event Description

It was reported on pr (b)(4): "had encountered this incident about the kit's dilator today.The tip (gray part) seemed soft that it teared while advancing through the skin." pr (b)(4): "it also happened to [omitted] recently that both of them had to use the 5fr mst which we tried to avoid to prevent bleeding.".

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG
• Type of Device: 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: 11236921
• MDR Text Key: 230022859
• Report Number: 3006260740-2021-00062
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741155093
• UDI-Public: (01)00801741155093
• Combination Product (y/n): N
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1194108D4
• Device Lot Number: REES1267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR