MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 364880

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/03/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd received a box of samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was observed as 3 blisters had a dark colored foreign matter on the sealed edge of the blister packaging.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter 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 foreign matter.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® blood transfer device holder with female luer adapter there was foreign matter on device cannula.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: "foreign matter was found in 4 of 6 tear-off packages packed in a set.".

Manufacturer Narrative

H.10 correction: this mdr dt supersedes all previous mdr dts.The previous mdr dt was completed in error with the incorrect reportability.This is not mdr reportable.There was no report of serious injury, medical intervention, or reportable device malfunction.Foreign matter on the outside of the product is unlikely to affect product function nor harm a patient or user.

Event Description

It was reported when using the bd vacutainer® blood transfer device holder with female luer adapter there was foreign matter on device cannula.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: "foreign matter was found in 4 of 6 tear-off packages packed in a set.".

• Brand Name: BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13119429
• MDR Text Key: 284838898
• Report Number: 2618282-2021-00081
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903648806
• UDI-Public: 50382903648806
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991088
• 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: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 364880
• Device Catalogue Number: 364880
• Device Lot Number: 1082743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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