MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number 5C4129

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Device Slipped (1584)

Patient Problem Peritonitis (2252)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Two capd patients were found to have their connection between their pd catheter titanium adapter/transfer set very loose and no symptoms.Patient v.Catheter transfer tubing fell off on [redact date], patient reported to staff on [redact date].Date of pd catheter insertion [redact date].Patient d.Reported to staff [redact date] about transfer tubing disconnect.Patient was unsure of the date tubing disconnect happened.Pd catheter inserted in or on [redact date].They both now are being treated for peritonitis.Manufacturer response for set, administration, for peritoneal dialysis, disposable, locking titanium adapter for peritoneal dialysis catheter (per site reporter) [redact date] report incident to representatives from baxter.[redact date] baxter reference ¿ (b)(4) email communication from global product surveillance, baxter international inc.

• Brand Name: LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15462265
• MDR Text Key: 300362553
• Report Number: 15462265
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/13/2022,09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 5C4129
• Device Catalogue Number: 5C4129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/13/2022
• Device Age: 2 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 22995 DA
• Patient Sex: Male
• Patient Weight: 134 KG
• Patient Race: White