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

Catalog Number 302558

Device Problem Malposition of Device (2616)

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

Event Date 03/24/2022

Event Type  malfunction  

Event Description

It was reported while using bd plastipak¿ syringes the stopper was poorly positioned.There was no report of patient impact.The following information was provided by the initial reporter: when the aspiration began it was noticed that the drug was no longer coming out, so the needle fitting was verified looking for possible air entrance but it was not found, so they continued aspirating the drug when it was noticed that the stopper was bad positioned causing a leakage past stopper.The aspiration was suspended with 2ml of drug inside the syringe.After injecting it, the syringe was discarded and another one was used to administered the 8ml left.

Manufacturer Narrative

Patient¿s birthday was not provided, (b)(6) was used based on age of patient.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd plastipak¿ syringes the stopper was poorly positioned.There was no report of patient impact.The following information was provided by the initial reporter: when the aspiration began it was noticed that the drug was no longer coming out, so the needle fitting was verified looking for possible air entrance but it was not found, so they continued aspirating the drug when it was noticed that the stopper was bad positioned causing a leakage past stopper.The aspiration was suspended with 2ml of drug inside the syringe.After injecting it, the syringe was discarded and another one was used to administered the 8ml left.

Manufacturer Narrative

H6: investigation summary three photos received by our quality team for investigation.Upon visual inspection, a used syringe is displayed with an inclination of the stopper.It is not possible to observe a damaged stopper from the images, physical samples are necessary to further analyze.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.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• 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: 14196835
• MDR Text Key: 290153145
• Report Number: 9614033-2022-00030
• 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: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302558
• Device Lot Number: 1337210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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
• Patient Age: 35 YR
• Patient Sex: Female