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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HYPODERMIC NEEDLE

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BECTON DICKINSON, S.A. BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE HYPODERMIC NEEDLE Back to Search Results
Catalog Number 300865
Device Problem Positioning Problem (3009)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); No Code Available (3191)
Event Date 04/14/2017
Event Type  Death  
Manufacturer Narrative
Medical device expiration date: unknown. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown. Udi #: (b)(4).
 
Event Description
It was reported that the plunger of the bd plastipak¿ 50ml concentric luer lock syringe was difficult to glide while administering the drug noradrenadin with a fresenius syringe pump. The speed of the noradrenaline was 9ml/h and the patient was very unstable. The patient's blood pressure dropped dramatically and it was unable to be increased, which resulted in the death of the patient. Specific medical interventions that the patient may have received were not reported.
 
Manufacturer Narrative
Additional information: describe event or problem: the pump syringe stopped and alarmed during administration of the noradrenaline.
 
Event Description
Additional information: the pump syringe stopped and alarmed during administration of the noradrenaline.
 
Manufacturer Narrative
Results: a sample was not returned for evaluation. Since the lot number affected in this incident is unknown (b)(4) units of the lots sold to this customer in the last 2 years are evaluated: 1410307, 1412260, 1412247, 1412258, 1501287, 1502247, 1503292, 1503297, 1505272, 1506238, 1507299, 1508225, 1510218, 1511243p, 1512227p, 1512232p, 1602225p, 1603227, 1604232p, 1604250p, 1605256p, 1606221p, 1607253p, 1607259p, 1609236p, 1610234p, 1610252p, 1612236p, 1611244p, 1702235p, 1703212p, 1703247p, 1703290p. No damage or molding defect can be observed in any of the device history records. Break out and sustaining force test were performed with 5 retained samples of the 33 lots. All the results are acceptable. Pump test is performed with 5 retained samples of the 33 lots. All the results are acceptable. Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode. According to these results of the dhr review and retention sample investigation, no manufacturing defect has been found in these lots that could be related to this defect.
 
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Brand NameBD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
Type of DeviceHYPODERMIC NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6663830
MDR Text Key78290536
Report Number3003152976-2017-00003
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number300865
Device Lot NumberUNKNOWN
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 Received06/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 06/23/2017 Patient Sequence Number: 1
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