MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368835

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Bruise/Contusion (1754)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that during use with 2 lots of bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder the holder separated from the device.Patient was bruised, no other impact was reported.The following information was provided by the initial reporter: holder dropped off; when did the incident occur? during use; the technician has survived the situation with a fright, but the patient has probably received a serious bruise on his hand as a result of sampling.It is very likely that the needle has also punctured the back of the vein when it has detached from the sleeve during the illegal use of the tube.The sampler has more than 20 years of experience and was familiar with the product.The customer still has the needle if you need it for further examinations."they can¿t no which lot it was.Both lots are now in use.Patient got a big bruise.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2271619; d.4.Medical device expiration date: 31-oct-2025; h.4.Device manufacture date: 28-sep-2022; d.4.Medical device lot #: 2243916; d.4.Medical device expiration date: 31-aug-2025; h.4.Device manufacture date: 31-aug-2022.H.6 investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for hub - holder separation was observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 vacutainer tubes, and the issue of hub - holder separation was not observed.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode hub - holder separation.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

• Brand Name: BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17958532
• MDR Text Key: 325962550
• Report Number: 9617032-2023-01484
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 30382903688358
• UDI-Public: (01)30382903688358
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368835
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• 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