MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REPAIR KIT, 7FR; CENTRAL VENOUS CATHETER REPAIR KIT

Model Number	7741700
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930); No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review 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.
Event or Problem Description
It was reported that after the central venous catheter was repaired, it allegedly leaked.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged leak as no objective evidence has been provided to confirm any alleged deficiency with the repair kit.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include sharp instrument damage, over-pressurization, and improper repair procedure; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Event or Problem Description
It was reported that after the central venous catheter was repaired, it allegedly leaked.There was no reported patient injury.

• Brand Name: REPAIR KIT, 7FR
• Common Device Name: CENTRAL VENOUS CATHETER REPAIR KIT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8189675
• Report Number: 3006260740-2018-03710
• Device Sequence Number: 16804440
• Product Code: LJS
• UDI-Device Identifier: 00801741037726
• UDI-Public: (01)00801741037726
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K871998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7741700
• Device Catalogue Number: 7741700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 03/20/2019
• 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: Hospitalization
• Patient Age: 64 YR