MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK SYRINGE 10ML LUER-LOK

Catalog Number 990172

Device Problems Contamination /Decontamination Problem (2895); Packaging Problem (3007)

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

Event Date 03/07/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the package integrity is compromised with a bd plastipak¿ syringe 10ml luer-lok¿.The following information was provided by the initial reporter, translated from (b)(6) to english: product is with the package opened.

Manufacturer Narrative

Investigation summary: it was performed the dhr, quality notification and maintenance analysis and occurrences potentially related to the defect was observed.The sample sent by the customer was verified and it was possible to observe packaging seal opened ¿ seal failure.The cause for the problem is failure at seal station at packaging machine, caused by a misaligned syringe plunger rod, which caused the seal failure.The operators will be notified of this complaint.The defect identified from this complaint will be monitored for trend evaluation.

Event Description

It was reported that the package integrity is compromised with a bd plastipak¿ syringe 10ml luer-lok¿.The following information was provided by the initial reporter, translated from portuguese to english: product is with the package opened.

• Brand Name: BD PLASTIPAK SYRINGE 10ML LUER-LOK
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8476203
• MDR Text Key: 146511928
• Report Number: 3003916417-2019-00180
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 990172
• Device Lot Number: 8352876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other