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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD; STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD; STOPCOCK Back to Search Results
Catalog Number 394601
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2022
Event Type  malfunction  
Event Description
It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold packaging was contaminated.The following information was provided by the initial reporter, translated from chinese to english: the warehouse management teacher reported and found that the outer packaging of the connecta was contaminated when inspecting the product; no photos provided.
 
Manufacturer Narrative
Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 20-sep-2022.H6: investigation summary: our quality engineer inspected the 200 samples submitted for evaluation.The reported issue of packaging issue - product packaging was confirmed upon inspection of the samples.Analysis of the sample showed that there were black specks of foreign matter.Bd determined that the cause of the black specs is associated to the printing process.However, the size of the black specs is considered to be within manufacturing specifications and is not considered a failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch was in compliance with our product specification requirements.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.
 
Event Description
It was reported that the bd connecta¿ multiflo¿ 3-way multiple infusion manifold packaging was contaminated.The following information was provided by the initial reporter, translated from chinese to english: the warehouse management teacher reported and found that the outer packaging of the connecta was contaminated when inspecting the product; no photos provided.
 
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Brand Name
BD CONNECTA¿ MULTIFLO¿ 3-WAY MULTIPLE INFUSION MANIFOLD
Type of Device
STOPCOCK
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15518770
MDR Text Key302343743
Report Number9610847-2022-00375
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number394601
Device Lot Number1158355
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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