MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 1ML 27GA 1/2IN P

Catalog Number 326716

Device Problem Missing Information (4053)

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

Event Date 06/15/2021

Event Type  malfunction  

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 that the syringe 1ml 27ga 1/2in p experienced missing label information.The following information was provided by the initial reporter: 1 shipping carton has been rejected because its label is damaged, inside the protection.

Event Description

It was reported that the syringe 1ml 27ga 1/2in p experienced missing label information.The following information was provided by the initial reporter: 1 shipping carton has been rejected because its label is damaged, inside the protection.

Manufacturer Narrative

H.6.Investigation: no physical samples were received; the investigation was performed based on the photo provided.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.The claim is considered confirmed since the defect is reproducible in the cube formation process, so the failure mode: feeding boxes in the arpac machine, is confirmed.H3 other text : see h.10.

• Brand Name: SYRINGE 1ML 27GA 1/2IN P
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12170671
• MDR Text Key: 262177791
• Report Number: 9614033-2021-00079
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• 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: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326716
• Device Lot Number: 1071209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2021
• 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