MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

Catalog Number 368650

Device Problems Loose or Intermittent Connection (1371); Difficult to Open or Close (2921); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown (b)(6).Bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.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 the safety valve on the bd eclipse¿ blood collection needle with luer adapter gets loose and leads to needlestick injuries.Packaging is difficult to open - including the safety cap, the safety cap is clicked onto plastic.No serious injury or medical intervention reported.

• Brand Name: BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER
• Type of Device: BLOOD COLLECTION 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: 7097950
• MDR Text Key: 94410431
• Report Number: 1024879-2017-00593
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903686506
• UDI-Public: 00382903686506
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K982541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 368650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other