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

Model Number	7742000
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 reaq0456 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.Supposedly groshong 9.5 dual lumen complete external 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.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of catheter damage was confirmed and the cause appeared to be use related.The product returned for evaluation was a repair body for a 9.5fr d/l groshong chronic catheter.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The returned product sample was evaluated and a split was observed 2mm proximal of the molded joint on the white luered extension leg.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: 'c' shaped split.Tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).The complainant reported that the catheter had required multiple repairs and the same extension leg which contained burst damage also contained a previous repair proximal of the burst site.It was unknown if the previous damage to that leg was of the same failure mode because the damaged portion of that extension leg was not returned for evaluation.Additionally, the original catheter which required repair was also not returned for evaluation and an assessment of that device was not possible.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) of reaq0456 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The original repaired device required additional repairs.Supposedly groshong 9.5 dual lumen complete external 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 WITH GROSHONG 9.5F 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: 6765759
• Report Number: 3006260740-2017-01221
• Device Sequence Number: 13658339
• Product Code: LJS
• UDI-Device Identifier: 00801741036804
• UDI-Public: (01)00801741036804
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K871998
• 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,Followup
• Report Date (Section B): 11/01/2017

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: 01/31/2020
• Device Model Number: 7742000
• Device Catalogue Number: 7742000
• Device Lot Number: REAQ0456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1