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

Model Number	N/A
Medical Device Problem Codes	Material Discolored (1170); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer, "brown discoloration after using scissors.The discoloration on the ring disappeared within a couple hours.While trimming statseal disc brown discoloration was noted to come off scissors.New ring and scissors obtained but picc had already been placed and scissors used to trim catheter.Statlock was used to secure picc.No issues as of 3/8/2023 will continue to monitor.There was no concomitant therapy as event occurred with picc placement.".
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 on a foam ring of a picc kit following the use of the included scissors is confirmed and was determined to be supplier related.The returned product was one pair of scissors and one foam disc that was partially cut.An initial visual observation showed no obvious discoloration with either returned product.The foam disc exhibited a triangle-shaped cut with material removed.The scissors were observed to be slightly bent.An initial functional test of cutting the foam disc with the returned scissors without manipulation revealed nothing remarkable and no observable discoloration.The scissors felt sticky while attempting to use them, and a functional test of rubbing the scissors together multiple times and subsequently cutting the foam disc where the scissors rubbed together revealed residues that were left behind by the scissors.A microscopic observation revealed nothing remarkable on the foam disc or the scissors initially; however, after the functional test of rubbing the scissors together several times and cutting the foam disc following the functional test, the foam disc appeared to have gray residues on from the scissors that could easily be wiped away.The complaint of discoloration on a foam disc due to scissors included in a picc kit is confirmed and was determined to be related to manufacturing.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.
Event or Problem Description
It was reported by the customer, "brown discoloration after using scissors.The discoloration on the ring disappeared within a couple hours.While trimming statseal disc brown discoloration was noted to come off scissors.New ring and scissors obtained but picc had already been placed and scissors used to trim catheter.Statlock was used to secure picc.No issues as of 3/8/2023 will continue to monitor.There was no concomitant therapy as event occurred with picc placement.".

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG TPS STYLET (4F) SL
• 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: 16632026
• Report Number: 3006260740-2023-01027
• Device Sequence Number: 20167064
• 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: Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 55 YR
• Patient Sex: Female
• Patient Weight: 96 KG