MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) ABBOTT TUBE EDTA PLH 13X75 2.0 PNK; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364676

Device Problem Contamination (1120)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported when using the abbott tube edta plh 13x75 2.0 pnk there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: there was "foreign matter in/ on tube.".

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 abbott tube edta plh 13x75 2.0 pnk there was foreign matter in the tube(s) biological and non-biological.The following information was provided by the initial reporter.The customer stated: there was "foreign matter in/ on tube.".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 21-jun-2022 h6: investigation summary bd received 900 samples and 4 photos were returned by the customer in support of this complaint.A visual examination of the samples and photos was performed and revealed wrinkled shelf labels, torn shelf labels, upside down tube in shelf pack, and holes in shrinkwrap.Additionally, 100 retentions were visually inspected with no issues with the tube labels, the shrinkwrap, and the shelf pack label being identified.Bd was able to confirm the customer¿s indicated failure mode with the samples and photos provided.The exact cause of the customer¿s failure modes could not be determined.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.

• Brand Name: ABBOTT TUBE EDTA PLH 13X75 2.0 PNK
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14950957
• MDR Text Key: 303045235
• Report Number: 1917413-2022-00370
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080751
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 364676
• Device Lot Number: 2048364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2022
• 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