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

Catalog Number	386170
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 prior to use it was noticed that the persist package leaked in start pak with a bd iv start pak w/persist, tegaderm.This occurred with 3 separate iv start paks.The following information was provided by the initial reporter, translated from spanish to english: 3 pieces are stained as the envelope is broken with iodine.
Event or Problem Description
It was reported that prior to use it was noticed that the persist package leaked in start pak with a bd iv start pak w/persist, tegaderm.This occurred with 3 separate iv start paks.The following information was provided by the initial reporter, translated from spanish to english: 3 pieces are stained as the envelope is broken with iodine.
Additional Manufacturer Narrative
H.6.Investigation: bd was able to verify the customer¿s indicated failure mode on the three samples provided but cannot be confirmed to the manufactured process.During the manufacture of this product, the bd persist single package is rounded and inspected 100% for contamination and smears.During the 100% inspection of rounded corners process were found a very small amount of contaminated and smeared persist packages and discarded by our operators.Then these bd persist single packages were packaged along with other components and re-inspected 100% again for any damage and foreign materials.Based on investigation results to date, root cause cannot be determinate.Material 386170 with lot number 8148544 was manufactured on june 29, 2018, with order quantity of 50,400 ea.Persist single rnd corners (y2618aam) lots used were 8116522 and 8150511 for the lot reported and persist single (8006838) lot used was 68506.No qn¿s were found for lots 8116522, 8150511 and 68506 in sap and incoming inspection records.

• Brand Name: BD IV START PAK W/PERSIST, TEGADERM
• Common Device Name: IV START KIT
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8739516
• Report Number: 9610847-2019-00433
• Device Sequence Number: 1680750
• 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): 08/16/2019

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: 11/30/2020
• Device Catalogue Number: 386170
• Device Lot Number: 8148544
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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