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

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.

• Brand Name: BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE
• Type of Device: HYPODERMIC 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 Key: 6663830
• MDR Text Key: 78290536
• Report Number: 3003152976-2017-00003
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• 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 Received: 06/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300865
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Death