MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD IV START PAK¿; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	386170
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd iv start pak¿ experienced leakage.The following information was provided by the initial reporter: 1bx (25ea) found having leakage upon delivery to customer.
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the 5 photos submitted for evaluation.The reported issue of leakage was confirmed upon inspection of the sample photos.Analysis of the sample photos showed that the iodine packet within the packaging had burst and was leaking.Bd determined that the cause of the failure was not related to our manufacturing process, since the iodine packets are from a supplier.Actions have been taken to notify the supplier of the failure mode.Production records were reviewed, and this batch meets our manufacturing specification requirements.
Event or Problem Description
It was reported that the bd iv start pak¿ experienced leakage.The following information was provided by the initial reporter: 1bx (25ea) found having leakage upon delivery to customer.

• Brand Name: BD IV START PAK¿
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17545750
• Report Number: 9610847-2023-00229
• Device Sequence Number: 7570498
• Product Code: FPA
• UDI-Device Identifier: 30382903861706
• UDI-Public: (01)30382903861706
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 386170
• Device Lot Number: 2152627
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown