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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 ANGIOCATH¿ 16 G X 1.88 IN INTRAVASCULAR CATHETER

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH¿ 16 G X 1.88 IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 388330
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/11/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: samples/ photos: according to the visual analysis of the photos, it was not possible to confirm the complaint. For this product catalog the date of manufacture and the batch are stamped on the film and the expiration date on the blister is printed on the back of the packaging, ie on the top web containing the following description: "expiration date: 5 years after manufacturing". Investigation conclusion: not confirmed: bd was unable to confirm this complaint. Investigation comments: this complaint could not be confirmed as the expiration date is on the back of the packaging, printed on the paper containing the words: "expiration date: 5 years after manufacturing" and the manufacturing date is stamped on the film, as on the photos of the claimed samples. In addition, this date format for this type of catalog (national angiocath) is contained in internal document (b)(4). Based on the analysis of the photos, no root cause was assigned to this incident, since the complaint was not confirmed. Rationale: based on a severity assessment and occurrence it was determined that no capa is required at this time. The complaint was added to the complaint database for trend analysis, which is regularly monitored. Dhr review: device history record analysis was not performed since due to the analysis of the photos it was not a manufacturing failure of the manufacturing of the product.
 
Manufacturer Narrative
A sample is not available for evaluation. Customer photos were submitted. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed. Udi#: (b)(4).
 
Event Description
It was reported that a gynecological nurse noticed the blister information on a bd angiocath¿ 16 g x 1. 88 in contained only the manufacturing date but not the expiration date. The missing information was found post use. There was no injury or medical intervention reported.
 
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Brand NameBD ANGIOCATH¿ 16 G X 1.88 IN
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6843594
MDR Text Key253853584
Report Number9610048-2017-00021
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K950301
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2020
Device Catalogue Number388330
Device Lot Number5065173
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/13/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/05/2017 Patient Sequence Number: 1
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