MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA PLEURAL/PERITONEAL DRAINAGE KIT 1L; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number	4992209
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebv1918 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the aspira drainage catheter was leaking from the hub.No additional information provided.
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 leaking aspira is confirmed, use related.The sample returned is one aspira catheter.A large slit is visible 3 cm distal of the cuff.The edges of the slit were very smooth and fit together well.The interior surfaces were striated in a manner consistent with pattern transfer from a grind sharpened instrument such as a scalpel.Clamping proximal of the slit and pressurization of the catheter did not reveal any proximal or luer leaks.As the damage is consistent with sharp instrument damage, the complaint is confirmed, use related.A lot history review (lhr) of rebv1918 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the aspira drainage catheter was leaking from the hub.No additional information provided.

• Brand Name: ASPIRA PLEURAL/PERITONEAL DRAINAGE KIT 1L
• Common Device Name: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7404506
• Report Number: 3006260740-2018-00647
• Device Sequence Number: 16289019
• Product Code: PNG
• UDI-Device Identifier: 10801741091145
• UDI-Public: (01)10801741091145
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K110396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: 4992209
• Device Catalogue Number: 4992209
• Device Lot Number: REBV1918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2018
• Event Location: Home
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1