MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ASPIRA PLEURAL/PERITONEAL DRAINAGE KIT 1L; PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES

Model Number N/A

Device Problems Inflation Problem (1310); Device Operates Differently Than Expected (2913); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 for evaluation, as the device remains in the patient.A lot history review (lhr) of rebq2260 showed no other similar product complaint(s) from this lot number.

Event Description

On (b)(6) 2017 - hospice nurse reported to medical services and support (ms&s) that in home patient's aspira pleural catheter has not been drained successfully since (b)(6) 2017.Nurse stated there was "pinkish tinted fluid" in the external segment.After squeezing the bulb, the bulb would not re-inflate nor drain fluid.Ms&s advised the nurse that the patient may need to be seen in the er since the catheter will not drain.The catheter could be partially occluded.Nurse confirmed that there were no kinks in the line, no clamp on the catheter and that the bag is below the area needing to be drained.The bag/catheter connection was checked, patient was repositioned and after milking the line, the nurse was only able to get a few mls to drain.Ms&s stated the catheter may need to be flushed with saline or fibrinolysis agent.The nurse did not have a syringe for flushing at the time.No patient injury reported.

• Brand Name: ASPIRA PLEURAL/PERITONEAL DRAINAGE KIT 1L
• Type of Device: PERITONEAL DIALYSIS SYSTEM AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 6632469
• MDR Text Key: 77423576
• Report Number: 3006260740-2017-00763
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 00801741045035
• UDI-Public: (01)00801741045035(17)190331(10)REBQ2260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 4992301
• Device Lot Number: REBQ2260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Home
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1