MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN WOUND DRAINAGE

Device Problem Disconnection (1171)

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

Event Date 11/24/2021

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the hemovac drain was disconnected at the y port on (b)(6) 2021.Per additional information received on 11oct2021, it was reported that the hemovac drain ((lot - ngfu3954) was disconnected at the y port in post-anesthesia care unit on (b)(6) 2021.Per additional information received on (b)(6) 2021, the affected hemovac lots were (lot - unk) occurred on (b)(6) 2021, (lot - ngfr5257) occurred on (b)(6) 2021, (lot - ngfs4374) occurred on (b)(6) 2021, (lot - unk) occurred on (b)(6) 2021, (lot - unk) occurred on (b)(6) 2021.Per follow up information received via email on 22oct2021, customer did receive collection bags for drains and hemovac drains coming apart at the y connector.Usually, it happened at home, but the patient will reconnect, and then the drain was pulled by a home care nurse.There was a complete separation of the drain at the y connector.It was very easy to come apart and reconnect.Customer also added that occasionally there was a need for medical treatment that was a direct line to a deep surgical space, thus a potential for surgical site infection, and sometimes this would require extra office visits with the surgeon to monitor the drain site or wound and possibly antibiotics if needed.Per follow up received via email on (b)(6) 2021, it was stated that there were a total of 9 patients.Some patients required no further follow up treatment and some patients required oral antibiotics, not necessarily related to drain.The drain usually came apart 2 to 3 days post operation.Patients were usually discharged home by then, they reconnected the ends back together.The surgical team was made aware of this.But the patient, thought there was a problem with the surgery and were very alarmed at any site of bleeding.They were reassured and instructed how to proceed.It was also stated that as of (b)(6) 2021, they were putting a sterile tegaderm on the hemovac drain y connector at the area of detachment and they had no further issues.

Manufacturer Narrative

The reported event was confirmed cause unknown.1 sample was confirmed to exhibit the reported failure.Visual evaluation of the photo sample noted one opened (without original packaging), used drainage tube with y connector.Visual inspection of the sample noted that the y connector disconnected from the drainage tube.The device specification could not be found as the product identity was unknown.It was also noted that the y connector was cut to match 0043610 per vs2012o, revision 4.No further testing could be done as no physical sample was returned.A potential root cause for this failure could be ¿error of inspector¿.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the (wound drainage) product ifus were found to be adequate based on past reviews.H11: section a through f - the information provided by bd represents all 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 bd.

Event Description

It was reported that the hemovac drain was disconnected at the y port on (b)(6) 2021.Per additional information received on 11oct2021, it was reported that the hemovac drain ((lot - ngfu3954) was disconnected at the y port in post-anesthesia care unit on (b)(6) 2021.Per additional information received on 12oct2021, the affected hemovac lots were (lot - unk) occurred on (b)(6) 2021, (lot - ngfr5257) occurred on (b)(6) 2021, (lot - ngfs4374) occurred on (b)(6) 2021, (lot - unk) occurred on (b)(6) 2021, (lot - unk) occurred on (b)(6) 2021.Per follow up information received via email on 22oct2021, customer did receive collection bags for drains and hemovac drains coming apart at the y connector.Usually, it happened at home, but the patient will reconnect, and then the drain was pulled by a home care nurse.There was a complete separation of the drain at the y connector.It was very easy to come apart and reconnect.Customer also added that occasionally there was a need for medical treatment that was a direct line to a deep surgical space, thus a potential for surgical site infection, and sometimes this would require extra office visits with the surgeon to monitor the drain site or wound and possibly antibiotics if needed.Per follow up received via email on 24nov2021, it was stated that there were a total of 9 patients.Some patients required no further follow up treatment and some patients required oral antibiotics, not necessarily related to drain.The drain usually came apart 2 to 3 days post operation.Patients were usually discharged home by then, they reconnected the ends back together.The surgical team was made aware of this.But the patient, thought there was a problem with the surgery and were very alarmed at any site of bleeding.They were reassured and instructed how to proceed.It was also stated that as of (b)(6) 2021, they were putting a sterile tegaderm on the hemovac drain y connector at the area of detachment and they had no further issues.

• Brand Name: UNKNOWN WOUND DRAINAGE
• Type of Device: WOUND DRAINAGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13025778
• MDR Text Key: 285234308
• Report Number: 1018233-2021-08171
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention