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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 5ML SYRINGE WITH 22GA 1-1/2IN NEEDLE SYRINGE AND NEEDLE

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BECTON DICKINSON, S.A. BD 5ML SYRINGE WITH 22GA 1-1/2IN NEEDLE SYRINGE AND NEEDLE Back to Search Results
Catalog Number 301943
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem No Information (3190)
Event Date 04/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(6). The original notification date was 4/26/2016. The incident was reviewed at that time and found to be non-reportable, based off the information received. Additional information was received on 6/21/2016 that made this incident mdr reportable. Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us. Medical device manufacture date: may 2015 result - the manufacturing site completed a photo evaluation of the suspect device on 5/20/2016, which revealed the tip broken, confirming the reported issue. A sample was received after this time, although no additional information was supplied upon review. Review of the device history record revealed no irregularities during the manufacture of the reported lot #1505208. Conclusion: - the material used to manufacture discardit syringes has been selected and tested to resist normal conditions of use. The assembling machines have an on-line detection system that inspects 100 % the syringes, rejecting automatically the syringes with broken parts like the tip of the barrel. Based on this fact, the syringe tip could break as a consequence of any imperceptible damage in the barrel at the moment of the use or some strong condition during handling or use of the product. An absolute root cause for this incident cannot be determined.
 
Event Description
It was reported that on (b)(6) 2016, before dialysis treatment, a nurse from the dialysis unit connected the suspect bd 5ml syringe to the polyester cuffed semi-permanent dialysis catheter at the internal jugular vein; return blood was drawn to determine position of the catheter. When the nurse inserted the tip of the syringe into the semi-permanent dialysis catheter, she found that the tip of the syringe was broken off inside the integrated needleless fitting of the semi-permanent dialysis catheter and could not be removed; therefore the existing dialysis catheter could not be accessed. To continue the treatment, the physician cut out the original fitting and installed a temporary one to complete the dialysis. This temporary catheter was replaced surgically with another dialysis catheter.
 
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Brand NameBD 5ML SYRINGE WITH 22GA 1-1/2IN NEEDLE
Type of DeviceSYRINGE AND NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key5798185
MDR Text Key49651910
Report Number3002682307-2016-00010
Device Sequence Number1
Product Code FMF
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 foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 06/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue Number301943
Device Lot Number1505208
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2016
Was Device Evaluated by Manufacturer? Yes
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: 07/15/2016 Patient Sequence Number: 1
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