MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN REPAIR KIT; INTRAVASCULAR CATHETER REPAIR KIT

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2017
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, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by the facility that on (b)(6) 2017 the surgery team was notified by rn of concern that broviac line has not been working well for the past two days.She reports the line has been infusing continuous iv fluids since admission on (b)(6) but she was told in report that the line has been difficult to flush.She was also told in report that when the dressing was changed that day, the line tubing looked like "the tubing is breaking".Mother reported she has been changing dressings once a week at home when they have not been in the hospital since the line was placed and reports that the tubing has not changed and has had no difficulty flushing.However, mother feels the tubing looked "twisted" today when she saw it during the dressing change by the bedside nurse and says it looks like it may have "pulled out a little".At that time, it was noted that there was a hole in the outer sheath of the broviac right where the skinny tubing turn into the fat tubing distally, but it was not leaking and a fluro study showed there was no leak.She was then scheduled for removal of broviac and replacement of broviac/port a week later after her counts recovered from chemo, but the line completely broke prior to that date and was removed on (b)(6) 2017.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 a damaged broviac catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4.2fr s/l broviac repair 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 just distal of the clamping over-sleeve.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 by the facility that on (b)(6) 2017 the surgery team was notified by rn of concern that broviac line has not been working well for the past two days.She reports the line has been infusing continuous iv fluids since admission on (b)(6) but she was told in report that the line has been difficult to flush.She was also told in report that when the dressing was changed that day, the line tubing looked like "the tubing is breaking".Mother reported she has been changing dressings once a week at home when they have not been in the hospital since the line was placed and reports that the tubing has not changed and has had no difficulty flushing.However, mother feels the tubing looked "twisted" today when she saw it during the dressing change by the bedside nurse and says it looks like it may have "pulled out a little".At that time, it was noted that there was a hole in the outer shealth of the broviac right where the skinny tubing turn into the fat tubing distally, but it was not leaking and a fluro study showed there was no leak.She was then scheduled for removal of broviac and replacement of broviac/port a week later after her counts recovered from chemo, but the line completely broke prior to that date and was removed on (b)(6) 2017.

• Brand Name: UNKNOWN REPAIR KIT
• 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: 6800384
• Report Number: 3006260740-2017-01314
• Device Sequence Number: 11155233
• Product Code: LJS
• UDI-Device Identifier: 00801741051814
• UDI-Public: (01)00801741051814
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K830256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 08/17/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 MO
• Patient Weight: 9