MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PLEURAL ESSENTIAL KIT; PATIENT CARE SUCTION APPARATUS

Catalog Number	4992508
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 rebp0006 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that there is a hole in the catheter.Another device was used to complete the procedure.No patient injury was reported.
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 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 a hole in the aspira catheter was confirmed and the damage appears to be use related.One aspira drainage catheter was returned for investigation.The overall length of the catheter was 74.5cm.What appears to be blood residue was observed in the fibers of the cuff.A breach in the tubing was observed 8mm distal to the cuff.The adjoining surfaces of the breach were microscopically examined and were noted to be glossy and striated, which is typical of sharp instrument damage.Functional testing revealed that fluid would leak from the sharp instrument cut in the tubing.The product ifu states, ¿do not allow the device to contact sharp instruments.Mechanical damage may occur.Use only smooth edged atraumatic clamps or forceps.¿.
Event or Problem Description
Facility reported to the sales rep that there is a hole in the catheter.Another device was used to complete the procedure.No patient injury was reported.

• Brand Name: PLEURAL ESSENTIAL KIT
• Common Device Name: PATIENT CARE SUCTION APPARATUS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6486055
• Report Number: 3006260740-2017-00402
• Device Sequence Number: 19239176
• Product Code: DWM
• UDI-Device Identifier: 10801741091169
• UDI-Public: (01)10801741091169(17)181231(10)REBP0006
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K110409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2017

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: 12/31/2018
• Device Catalogue Number: 4992508
• Device Lot Number: REBP0006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1