MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. IV START PAK W/PERSIST, TEGADERM; N/A

Model Number	386170
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that iv start pak w/persist, tegaderm came broken and had foreign matter on it.This was discovered before use.The following information was provided by the initial reporter: comes broken and stained.
Additional Manufacturer Narrative
H.6.Investigation summary a device history record review was performed for provided lot number 9151991.The review did not reveal any detected quality issues during the production process and all inspections were found to be within specification.To further investigate this incident, two picture samples were provided for evaluation by our quality engineer team.Through examination of the pictures, it appears that the leakage was coming from the persist package.Through examination of the picture, further damage could not identified and therefore, the complaint of broken product could not be substantiated.During the manufacturing process, the bd persist single package is inspected for signs of damage.At this time, a manufacturing related cause for this issue cannot be determined.A notification has been send to the suppliers affiliated with this product to further investigate this incident.
Event or Problem Description
It was reported that iv start pak w/persist, tegaderm came broken and had foreign matter on it.This was discovered before use.The following information was provided by the initial reporter: comes broken and stained.

• Brand Name: IV START PAK W/PERSIST, TEGADERM
• Common Device Name: N/A
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9489586
• Report Number: 9610847-2019-00749
• Device Sequence Number: 2860986
• Product Code: LRS
• UDI-Device Identifier: 30382903861706
• UDI-Public: 30382903861706
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 07/31/2021
• Device Model Number: 386170
• Device Catalogue Number: 386170
• Device Lot Number: 9151991
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other