MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED; CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "when the catheter was opened and the catheter was pre-flushed, a white foreign body was found flushed out of the catheter valve, and the catheter was afraid to use the catheter in the human body, and re-opened the new catheter for insertion." 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 is pending evaluation.Results are expected soon.
Additional Manufacturer Narrative
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 foreign material within the catheter was confirmed and the cause was determined to be manufacturing related.The product returned for evaluation was one 4fr single lumen groshong catheter.The sample was received with an inlaid stylet.A piece of white material was observed within the catheter at the distal end.Microscopic inspection of the catheter confirmed the presence of white material inside the catheter near the valve.The white material was removed from the catheter.It was glossy and appeared consistent with a semi-rigid polymer.The material was similar in color to the plastic stylet flushing connector.The manufacturing site has conducted awareness training in response to this event.
Event or Problem Description
It was reported by the customer "when the catheter was opened and the catheter was pre-flushed, a white foreign body was found flushed out of the catheter valve, and the catheter was afraid to use the catheter in the human body, and re-opened the new catheter for insertion." no other information was provided.
Event or Problem Description
It was reported by the customer "when the catheter was opened and the catheter was pre-flushed, a white foreign body was found flushed out of the catheter valve, and the catheter was afraid to use the catheter in the human body, and re-opened the new catheter for insertion." 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.
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, "when the catheter was opened and the catheter was pre-flushed, a white foreign body was found flushed out of the catheter valve, and the catheter was afraid to use the catheter in the human body and re-opened the new catheter for insertion." no other information was provided.

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC PERIPHERALLY INSERTED
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18049721
• Report Number: 3006260740-2023-04948
• Device Sequence Number: 18008766
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(17)241231(10)REGT4259
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/21/2024

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 7715405
• Device Lot Number: REGT4259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 03/22/2024; 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 03/26/2024; 06/18/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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 Sex: Unknown