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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refu0764 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "grease reported on the gray 3cg fin and scissors when sterile kit was open.".
Event or Problem Description
It was reported by the customer "grease reported on the gray 3cg fin and scissors when sterile kit was open.".
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), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a substance on a kit component is confirmed; however, the exact cause is unknown.One 4 fr single lumen powerpicc, one 3cg stylet, and one pair of scissors were returned for evaluation.An initial visual observation showed a dark, blackish brown substance on the scissors and a small amount on the tether of the stylet and the slide clamp of the extension leg of the t-lock.This substance was observed primarily on the scissors, particularly on the blades and around the hinge of the scissors.This substance was found to be somewhat tacky, and some of the substance was observed to flake off of the scissors when handled.A clear liquid was observed within the extension leg tubing of the t-lock.The movement of the scissor blades and arms was observed to be restricted and felt somewhat tacky, likely due to the amount of the substance on the returned scissors.The state of the returned samples made it difficult to determine when and where the kit components came into contact with the unknown substance.Possible causes include contamination prior to or after opening the kit.H3 other text: evaluation findings are in section h.11.

• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15136296
• Report Number: 3006260740-2022-02977
• Device Sequence Number: 5048228
• Product Code: LJS
• UDI-Device Identifier: 00801741182532
• UDI-Public: (01)00801741182532
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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: CK000887
• Device Lot Number: REFU0764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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