MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2N1333

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that one hundred sixty-four (164) non-dehp standard bore catheter extension sets were defective; further described as the packaging was falling apart in pieces (deteriorated).The issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual devices were not available; however, photographs of the samples were provided for evaluation.Visual inspection was performed to the photograph damage in the packaging was observed.The reported condition was verified.The cause of the damaged packaging was due to exposure of the environment (high sterility dose, high heat, extended time direct exposure to sunlight) resulting a quicker oxidation of the material, resulting in falling apart.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H6: investigation findings: remove c15, update to c13.H6: investigation conclusion: remove d06, update to d15.Update the reported cause to: the cause of the condition could not be determined via the photographs.Update the stated cause of environmental conditions to a possible cause.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito 00705
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14876415
• MDR Text Key: 295956427
• Report Number: 1416980-2022-03419
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412475394
• UDI-Public: (01)00085412475394
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N1333
• Device Lot Number: UR17B21094
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1