MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® ONE USE HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364815

Device Problems Fluid/Blood Leak (1250); Volume Accuracy Problem (1675); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® one use holder, the customer stated the holder would not thread which lead to leak and underfill.The following information was provided by the initial reporter.The customer stated: it was reported that the holder will not thread all the way flush.Customer says when threading holder onto the back of the push button ultratouch wing set, the holder will not thread all the way flush and there's a gap between the top of the holder and the hub of the wing set.This is causing the bd vacutainer tubes to underfill and in some cases, blood is leaking into the holder.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported when using the bd vacutainer® one use holder, the customer stated the holder would not thread which lead to leak and underfill.The following information was provided by the initial reporter.The customer stated: it was reported that the holder will not thread all the way flush.Customer says when threading holder onto the back of the push button ultratouch wing set, the holder will not thread all the way flush and there's a gap between the top of the holder and the hub of the wing set.This is causing the bd vacutainer tubes to underfill and in some cases, blood is leaking into the holder.

Event Description

It was reported when using the bd vacutainer® one use holder, the customer stated the holder would not thread which lead to leak and underfill.The following information was provided by the initial reporter.The customer stated: it was reported that the holder will not thread all the way flush.Customer says when threading holder onto the back of the push button ultratouch wing set, the holder will not thread all the way flush and there's a gap between the top of the holder and the hub of the wing set.This is causing the bd vacutainer tubes to underfill and in some cases, blood is leaking into the holder.

Manufacturer Narrative

H6: investigation summary no samples or photos were returned by the customer in support of this complaint.Lot number is unknown.Bd was unable to duplicate or confirm the customer¿s indicated failure mode because no samples or photos were returned, and lot number is unknown.Lot number is unknown; therefore, no retention samples are available.The device history records could not be reviewed as the lot number is unknown.

• Brand Name: BD VACUTAINER® ONE USE HOLDER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13550262
• MDR Text Key: 285833725
• Report Number: 1917413-2022-00079
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903648153
• UDI-Public: 00382903648153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364815
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• 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