MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that piccs are mis-marked on the measurements.Missing about 10cm has led to multiple inaccurate picc trims.I was training a brand new picc placer and the first picc she used we noticed the lack of markings and stopped the procedure and got a new kit.A specific number of affected devices or patients was not provided by the complainant.No other information was provided.
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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 missing depth markers for a powerpicc catheter is confirmed and was determined to be related to the manufacture of the product.One 4 fr s/l powerpicc catheter with a t-lock and 3cg stylet was returned for evaluation.An initial visual observation of the returned catheter and stylet revealed no obvious use residues throughout the device.The stylet was observed to be pulled out slightly from the rubber septum.Two small bends were observed at the proximal end of the stylet.It was observed that the depth markers were missing from the 23 cm depth marker to the 30 cm depth marker.The catheter was observed to be trimmed at the 42 cm depth marker.An initial visual observation of the returned photograph showed an opened picc kit with someone holding a catheter taught over the kit tray.A microscopic observation revealed no obvious use residues throughout the device.The depth markings from the 23 cm depth marker to the 30 cm depth marker were observed to be missing from the device.This failure was determined to be related to the manufacture of the device.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC, 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21965180
• Report Number: 3006260740-2025-02843
• Device Sequence Number: 18230503
• Product Code: LJS
• UDI-Device Identifier: 00801741155048
• UDI-Public: (01)00801741155048(11)250221(17)260228(10)REKN2046
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: 1174108D4
• Device Lot Number: REKN2046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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