MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Catalog Number 50-7510

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Suction Failure (4039)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Hold shaneeka 4.7 product is defective 07jan2020: spoke to wife (b)(6) who reported that one bottle had the cap completely off.The next four bottles had no vacuum.She was concerned and took her husband to the er same day.She reported they did a chest x-ray.Radiology came and drained using 6 bottles and a total of 5.5 l.Catheter is in patient's abdomen and was placed in (b)(6) 2019.Wife verified the x-ray was a chest x-ray which did not show any concerns.All bottles failed on same day.Husband usually drains 3000ml every other day.Last drain prior was as scheduled and there was no issues with the bottles from that drain.No additional intervention.Samples were thrown away.Wife will call back with lot details if available.Polc.

Manufacturer Narrative

Follow up emdr for correction.F10 device code updated from 4039 to 2993.

Event Description

Product is defective.07jan2020: spoke to wife (b)(6) who reported that one bottle had the cap completely off.The next four bottles had no vacuum.She was concerned and took her husband to the er same day.She reported they did a chest x-ray.Radiology came and drained using 6 bottles and a total of 5.5 l.Catheter is in patient's abdomen and was placed in (b)(6) 2019.Wife verified the x-ray was a chest x-ray which did not show any concerns.All bottles failed on same day.Husband usually drains 3000ml every other day.Last drain prior was as scheduled and there was no issues with the bottles from that drain.No additional intervention.Samples were thrown away.Wife will call back with lot details if available.Polc.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 9590882
• MDR Text Key: 187383585
• Report Number: 9680904-2020-00002
• Device Sequence Number: 1
• Product Code: PNG
• Combination Product (y/n): N
• PMA/PMN Number: K160437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 50-7510
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention