MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG CV CATHETER REPAIR KIT FOR USE W/ GROSHONG 9.5F & 5F DUAL-LUMEN CV CATH; INTRAVASCULAR CATHETER REPAIR KIT

Model Number	7740000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rezj1839 showed no other similar product complaint(s) from this lot number.Device not yet returned.
Event or Problem Description
The original repaired device required additional repairs, groshong dual lumen white extension leg repair segment.Post repair blood allegedly aspirated easily each time, therefore line breakage is supposedly not related to use of excess force to try to clear occlusion.

• Brand Name: GROSHONG CV CATHETER REPAIR KIT FOR USE W/ GROSHONG 9.5F & 5F DUAL-LUMEN CV CATH
• Common Device Name: INTRAVASCULAR CATHETER REPAIR KIT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6765755
• Report Number: 3006260740-2017-01222
• Device Sequence Number: 16390100
• Product Code: FOZ
• UDI-Device Identifier: 00801741037702
• UDI-Public: (01)00801741037702
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K904558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

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: 01/28/2020
• Device Model Number: 7740000
• Device Catalogue Number: 7740000
• Device Lot Number: REZJ1839
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1