MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA PLEURAL DRAINAGE TRAY 1L; PATIENT CARE SUCTION APPARATUS

Model Number	4992507
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2018
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 rebw1470 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they had an aspira catheter where the ingrowth cuff separated from the catheter during placement.No patient injury reported.
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 a detached cuff was confirmed and the damage appeared to be use related.One aspira drainage catheter was returned for investigation.The cuff was received separate from the catheter.Residue from use was observed throughout the cuff fibers.A microscopic examination revealed that adhesive remained attached to the catheter where the cuff was positioned.Impressions of the cuff fibers were visible in the adhesive that remained on the catheter.A breach in the circumferential direction was observed in the tubing where the cuff was attached.The adjoining surfaces of the breach revealed a striated surface, which is indicative of sharp instrument damage.A tactual investigation revealed slight elastic weakness in the damaged area of the drainage catheter.It was reported that the cuff detached during placement.A combination of tensile stress and sharp instrument damage may have caused the cuff to detach.The product ifu states, ¿during placement: do not allow the device to contact sharp instruments.Mechanical damage may occur.Use only smooth edged atraumatic clamps or forceps.¿ a lot history review (lhr) of rebw1470 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that they had an aspira catheter where the ingrowth cuff separated from the catheter during placement.No patient injury reported.

• Brand Name: ASPIRA PLEURAL DRAINAGE TRAY 1L
• 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: 7229740
• Report Number: 3006260740-2018-00066
• Device Sequence Number: 19331486
• Product Code: DWM
• UDI-Device Identifier: 10801741091152
• UDI-Public: (01)10801741091152
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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: 4992507
• Device Catalogue Number: 4992507
• Device Lot Number: REBW1470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 01/30/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1