MAUDE Adverse Event Report: BARD ACCESS SYSTEMS REPLACEMENT CONNECTOR FOR GROSHONG CATHETER WITH INJECTION CAP; REPLACEMENT CATHETER

Model Number	7712800
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 rezh1989 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the physician is having repeated breaks in the external hub of the groshong, this is allegedly happening at least once a month.The physician states that it is happening with the initial device and the repair kit.He stated that it has been happening for years and he thinks it is a design flaw.He reported that it breaks a the end every time.

• Brand Name: REPLACEMENT CONNECTOR FOR GROSHONG CATHETER WITH INJECTION CAP
• Common Device Name: REPLACEMENT CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7419465
• Report Number: 3006260740-2018-00652
• Device Sequence Number: 16462330
• Product Code: LJS
• UDI-Device Identifier: 00801741087028
• UDI-Public: (01)00801741087028
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: 7712800
• Device Catalogue Number: 7712800
• Device Lot Number: REZH1989
• 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: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1