MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD A-LINE¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	364356
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 3151661 d4.Medical device expiration date: 30-jun-2025 h4.Device manufacture date: 31-may-2023 d4.Medical device lot#: unknown d4.Medical device expiration date: unknown h4.Device manufacture date: unknown b3: date of event is unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that while using bd a-line¿, clotting was seen in 5 syringes with a known lot number and an unspecified number of syringes with unknown lot numbers.No patient impact reported.
Event or Problem Description
It was reported that while using bd a-line¿, clotting was seen in 5 syringes with a known lot number and an unspecified number of syringes with unknown lot numbers.No patient impact reported.
Additional Manufacturer Narrative
H.6 investigation summary.Material #: 364356.Lot/batch #: 3151661 and unknown.Bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for clotting with the incident lot was not observed.Additionally, (b)(4) retention samples from bd inventory were evaluated for their heparin content and no issues were observed relating to clotting as all samples met specifications.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 is unable to be confirmed for the indicated failure mode clotting.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.

• Brand Name: BD A-LINE¿
• Common Device Name: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18902938
• Report Number: 9617032-2024-00364
• Device Sequence Number: 18114526
• Product Code: JKA
• UDI-Device Identifier: 50382903643566
• UDI-Public: (01)50382903643566
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K022426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2024

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
• Operator of Device: Other
• Device Catalogue Number: 364356
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown