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

Model Number 367957

Device Problem Break (1069)

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

Event Date 04/25/2023

Event Type  malfunction  

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6).H.6.Investigation summary: bd had not received samples, but one (1) photo was provided for investigation.The photo was reviewed and the indicated failure mode for molding defects was observed.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of molding defects was not observed.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 has been confirmed for the indicated failure mode molding defects.Bd was not able to identify a root cause for the indicated failure mode.H3: see h.10.

Event Description

It was reported that prior to use with bd vacutainer® sst¿ ii advance plus blood collection tubes the lid was discovered to be broken.The following information was provided by the initial reporter, translated from chinese to english: the patient suffered from pain and discomfort under the xiphoid process for 1 month, and was diagnosed with hydrocardia.At 07:36 on (b)(6) 2023, he was admitted to the hospital at 07:36.When the nurse took blood for his blood routine examination, he found that the shield of the vacuum blood collection tube was damaged and could not be used normally.He immediately replaced it with another vacuum blood collection tube for use.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES
• 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 ; 8448235433
• MDR Report Key: 16981894
• MDR Text Key: 315764972
• Report Number: 9617032-2023-00592
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679572
• UDI-Public: (01)50382903679572
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 05/12/2023

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: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 367957
• Device Catalogue Number: 367957
• Device Lot Number: 2084349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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