MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) UNKNOWN BD VACUTAINER SST BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367988

Device Problem Expiration Date Error (2528)

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

Event Date 09/14/2022

Event Type  malfunction  

Event Description

It was reported when using the unspecified bd vacutainer sst blood collection tube, the user identified the tubes were used past the expiry date.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that they used expired tubes.Customer contacted ts on (b)(6) with shelf life and gel deterioration inquires.Upon mis investigation it was notes the expired sst tubes were used for patient sampling.

Manufacturer Narrative

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, (b)(4).Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

B.5.Describe event or problem: it was reported that low draw or underfill was found while using the bd vacutainer® sst¿ ii advance plus blood collection tubes.The following information was provided by the initial reporter: when using the tube, it found that the tube has low or no draw issue.D1: brand name: bd vacutainer® sst¿ blood collection tubes.D.3 medical device manufacturer:becton, dickinson & co., (bd).D.4.Medical device catalog #: 367988.D.4.Medical device expiration date: 2022-04-30.D.4.Medical device lot#: 1116444.D.4.Unique identifier (udi) #: (b)(4).G.1.Manufacturing location: becton, dickinson & co., (bd).G.4.Date received by manufacturer: 09/29/2022.G.5.Pma / 510(k) #: bk050036.G.7.Type of report (manufacturers): follow-up 1.H.4.Device manufacture date: 2021-04-26.H.6.Investigation summary: bd had not received samples or photos 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 issues during manufacturing of the product.This complaint is unable to be confirmed.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

Event Description

It was reported when using the unspecified bd vacutainer sst blood collection tube, the user identified the tubes were used past the expiry date.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that they used expired tubes.Customer contacted ts on 9/14 with shelf life and gel deterioration inquires.Upon mis investigation it was notes the expired sst tubes were used for patient sampling.

• Brand Name: UNKNOWN BD VACUTAINER SST BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15473673
• MDR Text Key: 304010437
• Report Number: 2243072-2022-01597
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679881
• UDI-Public: 00382903679881
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK050036
• 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,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: 367988
• Device Lot Number: 1116444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 09/23/2022
• Supplement Dates Manufacturer Received: 09/29/2022
• Supplement Dates FDA Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• 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