MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367528

Device Problems Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/11/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: bd had not received samples, but six (6) photos were provided for investigation.The photos were reviewed and showed that the shrink film on the top of the shelf pack was torn and 3 caps were cracked.Additionally 2 retained shelf packs were visually inspected, and no cracked caps and no torn packaging were found.Bd was able to confirm the customer¿s indicated failure mode of torn packaging and cracked cap from the photos 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.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the a broken lid/cap.The following information was provided by the initial reporter.The customer stated: "the customer reported that the film package was found to be torn.I found the top of the package was torn and the top of hemogard cap of 3 tubes had crack.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but six (6)photos were provided for investigation.The photos were reviewed and showed that the shrink film on the top of the shelf pack was torn and 3 caps were cracked.Additionally 2 retained shelf packs were visually inspected, and no cracked caps and no torn packaging were found.Bd was able to confirm the customer¿s indicated failure mode of torn packaging and cracked cap from the photos 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.H3 other text : see h.10.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the a broken lid/cap the following information was provided by the initial reporter.The customer stated: "the customer reported that the film package was found to be torn.I found the top of the package was torn and the top of hemogard cap of 3 tubes had crack.".

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15902225
• MDR Text Key: 307912083
• Report Number: 9617032-2022-01222
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023331
• 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: 12/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 367528
• Device Lot Number: 2153666
• 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: 06/02/2022
• 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