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

Catalog Number 367986

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

It was reported when using the bd vacutainer® sst¿ blood collection tubes, the device experienced expired tubes.This event occurred once.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that they used expired tubes.Sat oct 22 14:01:11 utc 2022 - patient fields updated: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.Sat oct 22 14:00:50 utc 2022 - patient fields updated: hazard, injury or erroneous results? no.Hazard, injury or erroneous results details.Paola mendoza : (b)(6) 2022 19:14:13 (gmt) subject: email (b)(6) 2022, 1:55:14 pm.User: paola mendoza.Created on: (b)(6) 2022 18:55:15.Call activity comment: information sent by e mail.Elizabeth hoosier : (b)(6) 2022 14:37:54 (gmt).Reviewed, all info present.Elizabeth hoosier : (b)(6) 2022 14:37:40 (gmt) non-complaint rationale - based on the information provided, our conclusion is that the concern cited does not meet our criteria of a complaint ¿ refer to complaint determination decision tree (b)(4).Catherine chong : (b)(6) 2022 09:42:43 (gmt) customer inquiry/problem: customer is inquiring on product stability data that would support the use of the tube 49 days past the expiry date.Customer stated that samples were taken in bd part number 367986 past the expiry date.The lot in question is 1230964 with an expiry date of 2022-08-31 and these were last used yesterday, october 18th.The expired tubes were discovered today, october 19th but customer cannot confirm how many were used although the site has only ever received 500 each of this lot so customer believed < 100 could have been impacted.Steps taken with customer: documented inquiry as request for information.Outcome/resolution: pending, transferred to trained associate to contact customer.Rationale why no complaint is required: request for information only, customer is not alleging a defect.Catherine chong : (b)(6) 2022 09:42:08 (gmt) subject: email (b)(6) 2022, 5:19:15 pm.User: catherine chong.Created on: (b)(6) 2022 09:19:15.Call activity comment: null.Catherine chong : (b)(6) 2022 09:35:43 (gmt) customer is inquiring on product stability data that would support the use of the tube 49 days past the expiry date.

Manufacturer Narrative

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® sst¿ blood collection tubes, the device experienced expired tubes.This event occurred once.The following information was provided by the initial reporter.The customer stated: "they used expired tubes." customer stated that samples were taken in bd part number 367986 past the expiry date.The lot in question is 1230964 with an expiry date of 2022-08-31 and these were last used yesterday, october 18th.The expired tubes were discovered today, october 19th but customer cannot confirm how many were used although the site has only ever received 500 each of this lot so customer believed < 100 could have been impacted.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but one (1) customer photo was received for review and analysis.Bd is unable to confirm the customers reported defect.Tube was expired prior to the awareness, however the failure mode cannot be confirmed due to the limited information provided.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.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• 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 & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15718546
• MDR Text Key: 303039086
• Report Number: 1024879-2022-00637
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903679867
• UDI-Public: 00382903679867
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK050036
• 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,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 367986
• Device Lot Number: 1230964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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