MAUDE Adverse Event Report: BAXTER HEALTHCARE - GUANGZHOU MINICAP; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 6AC4466

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that one edge of the foil packaging of forty five (45) minicaps were found opened.This issue was found before use with patient involvement.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The devices were returned and evaluations are complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed with the following results.Five of the samples were found with no defects.The aluminum foil was not opened and the sample met specifications.Twenty-seven of the samples were found to have the bottom seal opened and did not meet specifications.Thirteen of the samples had the pouch peeled down from the corners along the top of the opening.These did not meet specifications.Additionally, ten packages of companion samples were inspected with no issues noted.For the 40 samples for which the reported condition was verified, the cause was determined to be related to mishandling during distribution.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - GUANGZHOU; guangzhou
• Manufacturer (Section G): BAXTER HEALTHCARE - GUANGZHOU; no. 6 jiao yuan road; dong ji industrial district; guangzhou 51073 0; CH 510730
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6841741
• MDR Text Key: 84938598
• Report Number: 1416980-2017-07130
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 6AC4466
• Device Lot Number: GM1703062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2017
• 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: N
• Patient Sequence Number: 1