MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PRISTINE; DIALYSIS CATHETER

Model Number	5403230
Medical Device Problem Codes	Component Missing (2306); Device Markings/Labelling Problem (2911); Component Misassembled (4004); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation as well as photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2023).
Event or Problem Description
It was reported that prior to a dialysis catheter placement procedure, the labeling of the catheter allegedly found to be mislabeled.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation as well as photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2023).
Event or Problem Description
It was reported that prior to a dialysis catheter placement procedure, the labeling of the catheter allegedly found to be mislabeled.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to a dialysis catheter placement procedure, the incorrect component was allegedly found in the package.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one unsealed pristine 23cm catheter kit was returned for evaluation and two electronic photos were provided for review.Gross visual and dimensional evaluations were performed on the returned device.The dimensions measured during sample evaluation does not match the dimensions of the device (rm1923102) with the reported lot which is a 23cm catheter.Moreover the dimensions of the returned device matches with the material (rm1923104) which is a 33cm pristine catheter.However upon further review on the manufacturing, packaging, biometrics, printing and stocking process of the device with the particular lot shows no discrepancies noted related to incorrect sized device within package or incorrect specification printed on device.Therefore, the investigation is inconclusive for the reported inaccurate information, component misassembled and component missing issues as the device was returned with the packaging in unsealed condition and moreover the exact circumstances upon opening the package are unknown.A definitive root cause could not be determined based upon the available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 02/2023), g3, h6 (method).H11: h6 (device, result, conclusion).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.H3 other text : see h10.

• Brand Name: PRISTINE
• Common Device Name: DIALYSIS CATHETER
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13576927
• Report Number: 3006260740-2022-00421
• Device Sequence Number: 12144136
• Product Code: MSD
• UDI-Device Identifier: 00801741219047
• UDI-Public: (01)00801741219047
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K203767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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 Model Number: 5403230
• Device Catalogue Number: 5403230
• Device Lot Number: REFT0662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 02/22/2022
• Supplement Report FDA Received Date: 03/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2021
• 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
• Patient Sex: Unknown