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

Model Number	N/A
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regv1435 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that "some scissors from the kit that left discoloration on the stat seal disc when it was trimmed." additional information received from the customer: "the discoloration was brown.A new disc and scissors were obtained but picc had already been placed and the scissors were used to trim catheter.Patient is being monitored for potential complications.Patient is being treated for mssa bacteremia and pulmonary valve endocarditis.".
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 complaint of discoloration is confirmed; however, the root cause could not be determined.The product returned for evaluation was a pair of scissors.Microscopic inspection of the inside and outside of the scissor edges revealed spots of a reddish-brown residue, which appeared consistent with material oxidation.Although a reddish-brown residue was observed on the returned samples, it is unknown how the residue accumulated on the returned sample.Consequently, this complaint is confirmed as ¿cause unknown¿ at this time.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that "some scissors from the kit that left discoloration on the stat seal disc when it was trimmed." additional information received from the customer: "the discoloration was brown.A new disc and scissors were obtained but picc had already been placed and the scissors were used to trim catheter.Patient is being monitored for potential complications.Patient is being treated for mssa bacteremia and pulmonary valve endocarditis.".

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TPS STYLET (4F) (SINGLE-LUMEN)
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16461378
• Report Number: 3006260740-2023-00595
• Device Sequence Number: 19412226
• Product Code: LJS
• UDI-Device Identifier: 00801741152566
• UDI-Public: (01)00801741152566
• 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
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000819
• Device Lot Number: REGV1435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 91 KG