MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER BLOOD ALCOHOL DETERMINATION SODIUM FLUORIDE:100MG K OXALATE 20MG; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367001

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device lot #: 258121 was reported, however, this is not a lot# manufactured by bd.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: the customer did not provide bd pas with product catalog number or lot number information, when requested.After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It was reported that tubes were expired during use with an unspecified bd blood collection tube.The following information was provided by the initial reporter: it is reported that an expired tube was used on attorney's client.

Event Description

It was reported that tubes were expired during use with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.The following information was provided by the initial reporter: it is reported that an expired tube was used on attorney's client.

Manufacturer Narrative

The following fields have been updated with additional information received: b.5.Describe event or problem: it was reported that tubes were expired during use with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.The following information was provided by the initial reporter: it is reported that an expired tube was used on attorney's client.D.1.Medical device brand name: bd vacutainer® blood alcohol determination sodium fluoride:100mg k oxalate 20mg d.3.Medical device manufacturer: becton, dickinson & co.¿ broken bow, ne / 68822 d.4 medical device catalog #: 367001 d.4.Medical device lot #: 6216984 d.4.Medical device expiration date: 2018-08-31 d.4.Unique identifier (udi) #: 50382903670012 g.2 manufacturing location: becton, dickinson & co.¿ broken bow, ne / 68822 g.5.Pma / 510(k)#: k901449 h.4.Device manufacture date: 2016-08-03.

Event Description

It was reported that tubes were expired during use with a bd vacutainer® blood alcohol determinations sodium fluoride: 100mg potassium oxalate: 20mg.The following information was provided by the initial reporter: it is reported that an expired tube was used on attorney's client.

Manufacturer Narrative

H6: investigation summary bd had not received samples or photos from the customer for evaluation.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 non-conformances during manufacturing of the product.

• Brand Name: BD VACUTAINER BLOOD ALCOHOL DETERMINATION SODIUM FLUORIDE:100MG K OXALATE 20MG
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 10370819
• MDR Text Key: 204992089
• Report Number: 2243072-2020-01197
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• PMA/PMN Number: K901449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 367001
• Device Lot Number: 6216984
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other