MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported by the customer that needle guides in the picc kit are not allowing an easy safe passage of the needle.The plastic is preventing the needle from going all the way through the needle guide and shearing small bits of plastic from the needle guide.Not able to use needle guide and impacts the needle.Customer states it¿s all needle guides in all the kits.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.
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.
Event or Problem Description
It was reported by the customer that needle guides in the picc kit are not allowing an easy safe passage of the needle.The plastic is preventing the needle from going all the way through the needle guide and shearing small bits of plastic from the needle guide.Not able to use needle guide and impacts the needle.Customer states it¿s all needle guides in all the kits.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.
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 difficulty advancing the needle into the needle guide was confirmed and was determined to be manufacturing related.The products returned for evaluation were two 21ga pinpoint gt needle guides.Sample 1 appeared to exhibit some deformation.Sample 2 exhibited some plastic deformation and excess flash on the needle guides 0.5cm and 2cm.An attempt to pass a non-complainant 21ga needle through each of the needle guides revealed some resistance during advancement.Microscopic inspection of the needle guides revealed the proximal end was slightly overlapped.Plastic deformation and excess flash were observed on both sets of needle guides.The excess flash and overlapping of the proximal end of the needle guide likely occurred during device manufacture.The investigation will be forwarded to the manufacturing site for evaluation.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that needle guides in the picc kit are not allowing an easy safe passage of the needle.The plastic is preventing the needle from going all the way through the needle guide and shearing small bits of plastic from the needle guide.Not able to use needle guide and impacts the needle.Customer states it¿s all needle guides in all the kits.No other information was provided.Eight samples were returned for investigation.This report addresses all eight devices.

• Brand Name: BARD PICC
• 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: 20041594
• Report Number: 3006260740-2024-04617
• Device Sequence Number: 18126126
• Product Code: LJS
• UDI-Device Identifier: 00801741154713
• UDI-Public: (01)00801741154713
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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,Followup
• Report Date (Section B): 02/10/2025

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: 10/21/2024; 02/10/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/18/2024; 02/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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