MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN.; SAFETY ENGINEERED SAMPLE NEEDLE

Catalog Number 368609

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Blood Loss (2597)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: unknown.Results: photograph was returned that showed leakage.Ten customer samples were returned that showed no defect.A review of the device history record revealed no irregularities during the manufacture of the reported lot #5252587, 5203971, 6020623.Samples and photos were returned for lot numbers: 5203971, 6020623.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.

Event Description

It was reported that bd vacutainer® eclipse¿ blood collection needle, 21 g x 1.25 in.Needle came loose from holder during use which resulted in blood leakage.Eclipse needle used in combination with pronto holder.No serious injury, blood exposure or medical intervention reported.

• Brand Name: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, 21 G X 1.25 IN.
• Type of Device: SAFETY ENGINEERED SAMPLE NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7058700
• MDR Text Key: 93715117
• Report Number: 1024879-2017-00681
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903686094
• UDI-Public: 382903686094
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 368609
• Device Lot Number: 5252587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2015
• 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): Other