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

Catalog Number 364376

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported when using the bd a-line¿ (syringe w/o needle) the customer found that the black rubber was missing.This event occurred seven times.The following information was provided by the initial reporter.The customer stated: "syringes do not come with black rubber bung at the end of the syringes.".

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

After further evaluation of the complaint, it has been determined that the previously submitted report 9617032-2023-00765 was sent in error.There was no report of serious injury, medical intervention, or reportable device malfunction.Therefore this is not considered to be a reportable malfunction.

Event Description

It was reported when using the bd a-line¿ (syringe w/o needle) the customer found that the black rubber was missing.This event occurred seven times.The following information was provided by the initial reporter.The customer stated: "syringes do not come with black rubber bung at the end of the syringes.".

Event Description

It was reported when using the bd a-line¿ (syringe w/o needle) the customer found that the black rubber was missing.This event occurred seven times.The following information was provided by the initial reporter.The customer stated: "syringes do not come with black rubber bung at the end of the syringes.".

Manufacturer Narrative

H.6.Investigation summary: bd received 10 samples for investigation.The samples were evaluated by visual examination and the indicated failure mode for missing plunger stopper with the incident lot was observed in all 10 samples.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of missing plunger stopper 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 missing plunger stopper.The following fields were updated due to additional information: d9: device available for evaluation:  yes, d9: returned to manufacturer on:  2023-07-24.

• Brand Name: BD A-LINE¿ (SYRINGE W/O NEEDLE)
• 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: 17182223
• MDR Text Key: 317676262
• Report Number: 9617032-2023-00765
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K022426
• 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,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 364376
• Device Lot Number: 2081514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2022
• 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