MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HOHN PERCUTANEOUS 7F DUAL-LUMEN CATHETER BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reby0322 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby0322) have been reported from the same facility in (b)(4).
Event or Problem Description
It was reported that ward staff was unclamping the white hub of the catheter and while trying to flush the catheter, noticed a small puncture hole at the white hub of the catheter on the spot of where the clamp was placed.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leaking catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 7fr d/l hohn acute central venous 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 in the white-luered extension tubing.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).An occlusion was observed distal to the burst site, and this may have contributed to the failure.Forceful flushing against an occlusion can cause this type of failure.The nursing procedure manual can be found online at www.Bardaccess.Com and provides the following guidance: ¿do not use a syringe smaller than 10ml to flush or confirm patency.Patency should be assessed with a 10ml or larger syringe with sterile saline.Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the does.Do not infuse against resistance.Infusion pressures should never exceed 25 psi.Smaller syringes generate more pressure than larger syringes.¿ the nursing procedure manual also provides guidance for re-establishing catheter patency in the event the catheter becomes occluded or resistance is felt during flushing.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.
Event or Problem Description
It was reported that ward staff was unclamping the white hub of the catheter and while trying to flush the catheter, noticed a small puncture hole at the white hub of the catheter on the spot of where the clamp was placed.

• Brand Name: HOHN PERCUTANEOUS 7F DUAL-LUMEN CATHETER BASIC KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8947053
• Report Number: 3006260740-2019-02533
• Device Sequence Number: 2657857
• Product Code: LJS
• UDI-Device Identifier: 00801741074462
• UDI-Public: (01)00801741074462
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2019

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: N/A
• Device Catalogue Number: 0600730
• Device Lot Number: REBY0322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 09/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1