MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME MINICAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number SPC4466

Device Problems Unsealed Device Packaging (1444); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A peritoneal dialysis (pd) patient received a minicap in which the packaging was found to be unsealed.Subsequently the patient used the minicap and as a result experienced peritonitis.The cause of the packaging condition was not reported.It was reported that, prior to use, the patient noticed a compressed and unshaped physical appearance of the minicap packaging and also that the residual betadine was dried out.In spite of the noted damage, the patient proceeded to use the minicap.The treatment for and outcome of the peritonitis were not reported.It was not reported if the patient was hospitalized for the event or whether pd therapy was ongoing.No additional information is available.

Manufacturer Narrative

The peritonitis was manifested by turbid (cloudy) peritoneal dialysis effluent and abdominal pain.On unreported dates, the patient began unspecified antibiotic treatment for the peritonitis (dose, frequency and route were not reported) and the patient recovered from the event.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available; however, four companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6890895
• MDR Text Key: 87225331
• Report Number: 1416980-2017-07812
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: SPC4466
• Device Lot Number: 16H28H15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other