MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER, 4F SL, 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reew3112 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported when the kit was opened, a hair (long and light colored) was on top of the catheter portion of the kit.The lot reew3112.
Event or Problem Description
It was reported when the kit was opened, a hair (long and light colored) was on top of the catheter portion of the kit.
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), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a foreign material within a kit is inconclusive due to the condition in which the sample was returned.One 4 fr single lumen powerpicc 3cg kit was returned for evaluation.An initial visual observation showed the kit was returned open.A long, light brown hair was found on the inner side of the drape wrap next to the kit tray.Because the kit was returned open, it was not possible to determine when and how the observed hair came into contact with the kit; therefore, this complaint was inconclusive.H3 other text : evaluation findings are in section h11.

• Brand Name: POWERPICC CATHETER, 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
• MDR Report Key: 11308728
• Report Number: 3006260740-2021-00283
• Device Sequence Number: 2564394
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: CK000775A
• Device Lot Number: REEW3112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 06/17/2021
• 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