MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE LUER-LOK¿

Catalog Number 990175

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The photo and the sample sent by the customer were verified and it was possible to observe scale marking missing.The probable cause for the defect is related to failure at printing system at the marking machine entrance, allowing the defect product flow of the process.Investigation conclusion: confirmed: bd was able to confirm/ reproduce the incident in question.Samples/ photos analysis: a photo and sample were received, and it is possible observe scale marking missing.Dhr review: it was verified the batch record and the manufacturing date for this batch was january 2nd to 4th, 2018.The process inspections were performed and no records of this defect were found.The current controls at manufacturing process to detect the defect are performed by visual inspection with each 2 hours at 24 parts; qn review: no quality notification (qn) could lead to this issue for the batches involved in this complaint are observed.Maintenance review: no maintenance records that could related to defect was observed.Conclusion: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The photo and the sample sent by the customer were verified and it was possible observe scale marking missing.The probable cause for the defect is related to failure at printing system at the marking machine entrance, allowing the defect product flow of the process.Root cause description: it was performed dhr evaluation and maintenance occurrence was observed.Based on this occurrence the potential causes for the problem is: failure at printing system at the marking machine; the defect identified from this complaint will be monitored for trend evaluation.Rationale: based on the severity and occurrence a capa is not required.

Event Description

It was reported that some of the bd plastipak¿ syringe luer-lok¿ syringes were missing the scale marking.Noticed prior to use.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no device returned to manufacture: yes.

Event Description

It was reported that some of the bd plastipak¿ syringe luer-lok¿ syringes were missing the scale marking.Noticed prior to use.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD PLASTIPAK¿ SYRINGE LUER-LOK¿
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7665249
• MDR Text Key: 113544358
• Report Number: 3003916417-2018-00140
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 990175
• Device Lot Number: 7361552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other