MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK ¿ SYRINGE; PISTON SYRINGE

Catalog Number 302579

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/22/2022

Event Type  malfunction  

Event Description

It was reported that the bd plastipak ¿ syringe was found without scale markings before use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from (b)(6): "nursing staff detects that when opening the packaging of the insulin syringe, it is not graduated.".

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date.Date of event: unknown.The date received by manufacturer has been used.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary photos received for investigation.Upon visual inspection, incomplete scale marking lines are observed.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Possible root cause for scale marking is associated with failure in the marking process.

Event Description

It was reported that the bd plastipak ¿ syringe was found without scale markings before use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter, translated from spanish: "nursing staff detects that when opening the packaging of the insulin syringe, it is not graduated".

• Brand Name: BD PLASTIPAK ¿ SYRINGE
• Type of Device: PISTON 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14116439
• MDR Text Key: 289320082
• Report Number: 9614033-2022-00019
• 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: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302579
• Device Lot Number: 1071201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2021
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 70 KG