MAUDE Adverse Event Report: BD (BECTON DICKINSON)/CAREFUSION 2200, INC. BD/CAREFUSION PLEUREX DRAINAGE KIT (REF 50-7510); PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING

Model Number REF 50-7510

Device Problems Disconnection (1171); Delivered as Unsterile Product (1421); Component Missing (2306); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 and (b)(6) 2021, my father, a (b)(6)-year-old, wwii veteran, received shipments of qty 10/carefusion pleurex drainage kit (ref 50-7510) from two different distributors.The (b)(6) 2021 delivery was shipped from (b)(4) in (b)(4) and the (b)(6) 2021 shipment came from the (b)(4) in the us.In each case, upon opening the sealed kit, at least 1 kit in 10 was found to be non-sterile due to a defect, or parts omitted.These kits are sterile medical products manufactured by bd (becton dickinson) in the (b)(4) where they are assembled by hand and imported to the us (per bd complaint dept.Csr (b)(4) who called me 7/15/21 regarding my complaint.) the first defective shipment on (b)(6) 2021, came from carefusion distributor, "(b)(4)," based in (b)(4).This was the company recommended by the home nurses provided after surgery.Eventually, the ordering/shipment from (b)(4) in (b)(4) proved too slow and we were able to get the product through my father's (b)(6) provider.Therefore, the (b)(6) 2021 shipment was provided from whatever distributor is used by (b)(4) medical center in (b)(4).(b)(4) and the (b)(4) were both immediately notified of defective items in their shipment.These kits are used to drain excess pleural fluid directly from the patient's internal thorax, from tubes surgically implanted & emanating from the body on each side.Defective product sterility, especially during the covid pandemic, can be life threatening.The (b)(6) 2021 carefusion product from (b)(4) was missing the clear sheath protecting the sterility of the item's drain "probe", which gets inserted into the female, sterile drain port attached to the drain tube that goes right back into the thorax.The (b)(6) 2021 carefusion product had a disconnected "probe"/flow control/drain tube apparatus (that is normally attached to the top of the vacuum plunger on the 1000 ml drain bottle.) this disconnection defect allowed environmental bacteria, viruses, dust and other contaminants to enter into the detached end of the apparatus tube through the air, and thereby enter through the back end of the attached sterile probe (which gets inserted into the sterile, female, drain port, attached to the larger tube, that terminates directly into the patient's internal thorax.) luckily, we noticed both defects in time & did not use the nonsterile products, which have an insurance value of (b)(6) per kit.The lot numbers were photographed and reported to the providers.We still retain the actual (b)(6) 2021 product and package.No contact phone# or email for carefusion is on any label and the parent company, bd, is not listed.The phone number for the carefusion, (b)(4) distribution center, has a non-working number.On (b)(6) 2021 it took 6 hrs of my time & many disconnected calls before finally reaching anyone at carefusion willing to file a report.During my 5th attempt, a csr in (b)(4) refused to provide assistance to reach an employee who could take my complaint and she hung up on me.On my 6th call, after finally reaching someone at carefusion who would take my complaint, i contacted (b)(4) by phone and, at his request, forwarded a written complaint with photos.I also contacted (b)(6) office, since she often works with the (b)(4).After that call, i was contacted by (b)(4), lieutenant commander, us public health svc.Investigator & acting (b)(4) consumer complaint coordinator for the fda on 7/16/21.She requested that i forward the emailed complaint letter & photos sent to (b)(4) & requested they also be forwarded to (b)(4), which i did.I am contacting medwatch at her request.If you need more info, please contact (b)(4) direct at (b)(4) or email to her attention at (b)(4).She can provide a copy of my complaint w/photos.You may also contact (b)(4) and put "(b)(4) unsterile/defective carefusion pleurex kits" in the subject line.This is a life/death case.Both items are bd/carefusion pleurex drainage kit (ref 50-7510) (b)(6) 2021 item missing clear sheath on sterile "probe" obtained through (b)(4) lot 0001381450 (b)(6) 2021 sterile drain apparatus received detached from drain bottle thru (b)(4), in us.Lot 0001394160.Fda safety report id # (b)(4).

• Brand Name: BD/CAREFUSION PLEUREX DRAINAGE KIT (REF 50-7510)
• Type of Device: PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING
• Manufacturer (Section D): BD (BECTON DICKINSON)/CAREFUSION 2200, INC.
• MDR Report Key: 12203450
• MDR Text Key: 263233206
• Report Number: MW5102667
• Device Sequence Number: 2
• Product Code: PNG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 07/18/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/20/2023
• Device Model Number: REF 50-7510
• Device Lot Number: 0001394160
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 94 YR
• Patient Weight: 84