MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. Q-SYTE; STOPCOCK, I.V. SET

Catalog Number	385151
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
"it was reported that the package was damaged and that air was leaking from the package.While storing the products, the packaging was squeezed, what made them notice that it really collapsed: air was leaving the package.They did a water test, and bubbles came out of the package.(see movie in email) when did the incident occur? - before use as also discussed over the phone with kim, we have the following situation before us: an oka nurse saw her colleague ¿stuffing¿ bd q-syte ref 385151 into a drawer, pressing the packs together and the air ¿disappearing¿.She put some packs on her desk and they slowly filled back with air afterwards (after a few hours/days: back bulging packs).I held that packaging under water and applied pressure and air bubbles effectively came through (see video - lot 5307254).Afterwards, i went to get a new pack in the economizer and this pack effectively came out of the box (overpack), i also submerged it in water and applied light pressure (so less pressure than in the video), air bubbles came out here too.Lot number 5274103.Doesn't seem okay to me?".

• Brand Name: Q-SYTE
• Common Device Name: STOPCOCK, I.V. 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25162643
• Report Number: 9610847-2026-00206
• Device Sequence Number: 10642142
• Product Code: FPA
• UDI-Device Identifier: 00382903851515
• UDI-Public: (01)00382903851515(11)251006(17)280930(10)5274103
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: Health Professional
• Device Catalogue Number: 385151
• Device Lot Number: 5274103
• 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: 04/28/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown