MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GLIDEPATH 10F LONG-TERM DIALYSIS CATHETER, 12 CM

Model Number	5303120
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 06/2022).Device not returned.
Event or Problem Description
It was reported that prior to a procedure, the device was allegedly found to be mislabeled.There was no patient contact.
Event or Problem Description
It was reported that prior to a procedure, the device was allegedly found to be mislabeled.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was performed.This is the second complaint reported for this lot number.A dhr review is required.Manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint was caused by the mfg.Process.Investigation summary: the sample was not returned for evaluation.Although the device was not returned for evaluation, the complaint is confirmed for the reported mislabeling issue, as the investigation confirmed a labeling issue for the product catalog and lot number associated with this complaint.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: 06/2022).H11: section a through f ¿ the information provide by bd represents all 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: device not returned.

• Brand Name: GLIDEPATH 10F LONG-TERM DIALYSIS CATHETER, 12 CM
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10693311
• Report Number: 3006260740-2020-20151
• Device Sequence Number: 3282026
• Product Code: MSD
• UDI-Device Identifier: 00801741187292
• UDI-Public: (01)00801741187292
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K200627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: 5303120
• Device Catalogue Number: 5303120
• Device Lot Number: REEU2819
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 10/16/2020
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other