MAUDE Adverse Event Report: BAXTER HEALTHCARE - SWINFORD LOCKING TITANIUM ADAPTER; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number 5C4129

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The date of event was sometime between (b)(6) 2018.(b)(6).An actual device was returned for evaluation for the packaging issue.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received in its pouch.The pouch was peeled open on one side, which had been stapled.The pouch was labeled with chinese text indicating that the product was re-packaged and re-labeled in china.The reported event was verified during evaluation and the cause was determined to be the re-packaging and re-labeling by a non-baxter warehouse in china.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the package of a titanium adapter was broken.This was identified before use.There was no patient involvement.No additional information is available.

• Brand Name: LOCKING TITANIUM ADAPTER
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - SWINFORD; swinford, county mayo
• Manufacturer (Section G): BAXTER HEALTHCARE - SWINFORD; foxford road; swinford, county mayo ; EI
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7452823
• MDR Text Key: 106247676
• Report Number: 1416980-2018-02336
• Device Sequence Number: 1
• Product Code: KDJ
• UDI-Device Identifier: 00085412007403
• UDI-Public: (01)00085412007403
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152675
• 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
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/28/2021
• Device Catalogue Number: 5C4129
• Device Lot Number: 16L08H35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Date Manufacturer Received: 03/26/2018
• 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