MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER, 4F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 redv3533 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the ultrasound probe cover located inside the kit had a small hole in it causing gel to leak.
Event or Problem Description
It was reported that the ultrasound probe cover located inside the kit had a small hole in it causing gel to leak.
Additional Manufacturer Narrative
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), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking probe cover is confirmed; however, the exact cause is unknown.One 4 fr single lumen powerpicc with 3cg kit was returned for evaluation.An initial visual observation showed the kit was returned open and, among other kit components, a probe cover was returned within the open kit.Gel was observed in within the probe cover, which was returned folded into itself.A large slit was observed near the distal end of the probe cover, and the corners of this slit were observed to be plastically deformed.While handling the probe cover, a small amount of gel was observed to leak from one corner of the distal end of the probe cover on the side opposite the large slit.A microscopic observation revealed a very small tear in the probe cover near one corner of its distal end.Plastic deformation of the material was observed around this small tear.While the exact cause of the tear in the probe cover is unknown, possible causes include damage during handling or use.A lot history review (lhr) of redv3533 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC CATHETER, 4F SL, 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9937632
• Report Number: 3006260740-2020-01216
• Device Sequence Number: 16829667
• Product Code: LJS
• UDI-Device Identifier: 00801741188060
• UDI-Public: (01)00801741188060
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 11/30/2020
• Device Model Number: N/A
• Device Catalogue Number: CK000775A
• Device Lot Number: REDV3533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1