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

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

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 when the drain was pulled, a portion was retained in the patient.An additional procedure was required for it to be removed from the patient.

Manufacturer Narrative

The reported event was confirmed.A visual evaluation of the received photos noted a wound drain with a break at the end of the remaining portion, as well as approximately 0.5cm from that point.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the wound drainage product ifus are found to be adequate based on past reviews.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that when the drain was pulled, a portion was retained in the patient.An additional procedure was required for it to be removed from the patient.

• Brand Name: WOUND DRAINAGE
• Type of Device: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8180920
• MDR Text Key: 130898103
• Report Number: 1018233-2018-06084
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention