MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® NO ADDITIVE (Z) TUBES; SPECIMEN TRANSPORT & STORAGE CONTAINER

Catalog Number 366703

Device Problem Short Fill (1575)

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

Event Date 07/30/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® no additive (z) tubes lost vacuum.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.366703, batch no.9036729 it was reported that two consecutive waste tubes lost vacuum.Regarding the waste tube that was faulty¿ i have collected that information to report below.Two consecutive waste tubes losing vacuum.Switched to lavender tube and 3ml waste collected with vacutainer.Another used to get full h&h.

Manufacturer Narrative

The following fields have been updated with additional information: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 9036729.D.4.Medical device expiration date: 2020-08-31.H.4.Device manufacture date: 2019-02-05.D.4.Medical device lot #: 9036728.D.4.Medical device expiration date: 2020-08-31.H.4.Device manufacture date: 2019-02-05.

Event Description

It was reported that bd vacutainer® no additive (z) tubes lost vacuum.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.366703 batch no.9036729, 9036728.It was reported that two consecutive waste tubes lost vacuum.Regarding the waste tube that was faulty¿ i have collected that information to report below.Two consecutive waste tubes losing vacuum.Switched to lavender tube and 3ml waste collected with vacutainer.Another used to get full h&h.

Manufacturer Narrative

Investigation: bd received samples from the customer facility for investigation.The samples were draw tested and the customer's indicated failure mode for lost vacuum with the incident lot was not observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Even though the customer's indicated failure mode was not observed with the samples provided, bd has initiated further investigation relating to this issue through capa#260774.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.

Event Description

It was reported that bd vacutainer® no additive (z) tubes lost vacuum.This occurred on 2 occasions during use.The following information was provided by the initial reporter: material no.366703 batch no.9036729, 9036728 it was reported that two consecutive waste tubes lost vacuum.Regarding the waste tube that was faulty¿ i have collected that information to report below.Two consecutive waste tubes losing vacuum.Switched to lavender tube and 3ml waste collected with vacutainer.Another used to get full h&h.

• Brand Name: BD VACUTAINER® NO ADDITIVE (Z) TUBES
• Type of Device: SPECIMEN TRANSPORT & STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8932568
• MDR Text Key: 155854326
• Report Number: 1917413-2019-01979
• Device Sequence Number: 1
• Product Code: FMH
• UDI-Device Identifier: 50382903667036
• UDI-Public: 50382903667036
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/13/2019

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: 366703
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 07/31/2019; 07/31/2019
• Supplement Dates FDA Received: 09/06/2019; 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other