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

Catalog Number 990256

Device Problem Volume Accuracy Problem (1675)

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

Event Date 03/16/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 2077025.D.4.Medical device expiration date: 31-mar-2027.H.4.Device manufacture date: 18-mar-2022.D.4.Medical device lot #: 1168924.D.4.Medical device expiration date: 30-jun-2026.H.4.Device manufacture date: 17-jun-2021.

Event Description

It was reported that the bd plastipak¿ insulin syringe scale marking issues.The following information was provided by the initial reporter, translated from spanish to english: syringe came without graduation.

Event Description

It was reported that the bd plastipak¿ insulin syringe scale marking issues.The following information was provided by the initial reporter, translated from spanish to english: syringe came without graduation.

Manufacturer Narrative

Batch history analysis (dhr) was performed, quality notifications were checked, and no records potentially related to this defect were found.Checked maintenance records and found a maintenance order possibly related to the incident.For the defect of lack of the marking scale, the photos provided were evaluated and it is possible to verify the mentioned failure, then, bd confirms/reproduces the complaint.The analysis of the possible root cause for this failure is during the intervention carried out, which consists of replacing the printing drums to carry out volumetric tests of the repaired printing drums in accordance with the standard.In the returning to the released printing drum, there may have been a sequence of adjustments, which had an impact on the marking of the material together with the operational failure of the segregation of the material not ok.The production process has a quantitative inspection routine to maintain the statistical basis for the release of materials, which have visual and functional tests which are intended to contain possible defects that can be delivered to the market, where they were not defects identified during batch production.H3 other text : see h10.

• Brand Name: BD PLASTIPAK¿ INSULIN SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16666178
• MDR Text Key: 312791850
• Report Number: 3003916417-2023-00070
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990256
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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