MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SER PLASTIPAK 10ML S LS; PISTON SYRINGE

Catalog Number 990558

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/29/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 when using the bd ser plastipak 10ml s ls, the device experienced missing scale markings.This event occurred 44 times.The following information was provided by the initial reporter.The customer stated: we found that some 10ml bd syringes from lot 1105299 came ungraded.I separated from my inventory the ones that had this error, totaling 44 units.

Manufacturer Narrative

H6: investigation summary: photo received for investigation.Upon visual inspection, it is possible to observe missing scale marking on the syringe.Possible root cause, is related to a failure of the paint pump.Paint pump was repaired immediately after notification.A device history review was conducted for lot number 1105299.

Event Description

It was reported when using the bd bd ser plastipak 10ml s ls, the device experienced missing scale markings.This event occurred 44 times.The following information was provided by the initial reporter.The customer stated: we found that some 10ml bd syringes from lot 1105299 came ungraded.I separated from my inventory the ones that had this error, totaling (b)(4) units.

• Brand Name: BD SER PLASTIPAK 10ML S LS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13321657
• MDR Text Key: 295356693
• Report Number: 3003916417-2022-00008
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990558
• Device Lot Number: 1105299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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