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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (BASD) -3006260740 POWERPICC; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) Back to Search Results
Model Number N/A
Medical Device Problem Code Activation Problem (4042)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/30/2026
Type of Reportable Event Malfunction
Event or Problem Description
It was reported the green needle inside of their kit this past week had a faulty safety device.The green tip slid right off of the needle and did not stop at the tip.No one was injured.
 
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 device has not been received by the manufacturer for evaluation.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.
 
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Brand Name
POWERPICC
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
becky sparks
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key24378845
Report Number3006260740-2026-00924
Device Sequence Number13326413
Product Code LJS
UDI-Device Identifier00801741232152
UDI-Public(01)00801741232152(11)250116(17)260331(10)REJY2716
Combination Product (Y/N)Y
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K210264
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source User Facility
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 02/09/2026
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 Date03/31/2026
Device Model NumberN/A
Device Catalogue Number1174108D6
Device Lot NumberREJY2716
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/30/2026
Initial Report FDA Received Date02/18/2026
Was Device Evaluated by Manufacturer? (Y/N) No
Date Device Manufactured01/16/2025
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 Number1
Outcome Attributed to Adverse Event Other;
Patient SexUnknown
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