MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC CHANNEL DRAIN - JACKSON PRATT - 15F; CATHETER, IRRIGATION

Model Number JP-2188

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

Pt had jackson-pratt drain placed after mastectomy surgery on (b)(6) 2019.Pt presented to physician office on (b)(6) 2019 for drain removal.Nurse in office cut the suture and attempted to remove drain with normal tension.Part of drain broke off during removal and remained in pt, requiring physician to reopen mastectomy incision to retrieve remaining internal piece of drain.Upon examination after removal, the clear plastic connector that connected the white drain to the clear tubing was the part that had torn apart.

• Brand Name: CHANNEL DRAIN - JACKSON PRATT - 15F
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC
• MDR Report Key: 8727542
• MDR Text Key: 149473605
• Report Number: MW5087569
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JP-2188
• Device Catalogue Number: JP-2188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 88