MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGES; PISTON SYRINGE

Catalog Number 990172

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

It was reported that 2 of the bd plastipak¿ syringes had loose rubber plungers.Report 1 of 2.The following was received by the initial reporter: verbatim: we had problems with the 10ml syringes from lot 3107614 (bd).Several came with the plunger rubber loose, which prevented the creation of a vacuum for blood suction at the time of collection (the collector pulled the plunger up to the 10ml mark, but the syringe filled with air and only 2-3ml of blood was obtained).In addition, syringes with a broken tip were also found, preventing the insertion of the needle.

Manufacturer Narrative

E.1.Initial reporter phone #: (b)(6).A device evaluation is anticipated but has not yet begun.H3.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation summary: photos received by our quality team for investigation.Through visual evaluation, the stopper was incorrectly assembled to the plunger, distorted against the barrel wall.A device history review was performed for the reported lot 3107614, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the quality team's investigation, a root cause for stopper defect cannot be identified at this time.Stopper supplier have been notified of this incident to increase awareness of this matter.

Event Description

It was reported that 2 of the bd plastipak¿ syringes had loose rubber plungers.Report 1 of 2.The following was received by the initial reporter: verbatim: we had problems with the 10ml syringes from lot 3107614 (bd).Several came with the plunger rubber loose, which prevented the creation of a vacuum for blood suction at the time of collection (the collector pulled the plunger up to the 10ml mark, but the syringe filled with air and only 2-3ml of blood was obtained).In addition, syringes with a broken tip were also found, preventing the insertion of the needle.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17446263
• MDR Text Key: 321239499
• Report Number: 3003916417-2023-00199
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 08/30/2023

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
• Device Operator: Other
• Device Catalogue Number: 990172
• Device Lot Number: 3107614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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