MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ 3ML LUER-LOK¿ SYRINGE

Catalog Number 990174

Device Problem Break (1069)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7333731; medical device expiration date: 11/30/2022 ; device manufacture date: 11/30/2017.Medical device lot #: 7300698; medical device expiration date: 10/31/2022 ; device manufacture date: 10/31/2017.Medical device lot #: 5194433; medical device expiration date: 08/01/2020 ; device manufacture date: 07/24/2015.Medical device lot #: 7270884; medical device expiration date: 09/30/2022 ; device manufacture date: 09/29/2017.Medical device lot #: 7333734; medical device expiration date: 11/30/2022; device manufacture date: 11/30/2017.Medical device lot #: 7300698; medical device expiration date: 1031/2022 ; device manufacture date:10/31/2017.Medical device lot #: 7345941; medical device expiration date: 11/30/2022; device manufacture date: 12/12/2017.

Event Description

It was reported that the bd plastipak¿ 3ml luer-lok¿ syringes had damaged stoppers prior to use.

Manufacturer Narrative

The corrections are as follows: it was included that the device experienced leakage during use in addition to the aforementioned stopper damage.

Event Description

It was reported that the bd plastipak¿ 3ml luer-lok¿ syringes had damaged stoppers prior to use.

Manufacturer Narrative

Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The sample received: batch: 5194433 quantity: 1 / batch: 7270884 quantity: 1 / batch: 7300698 quantity: 21 / batch: 7333731 quantity: 2 / batch: 7333734 quantity: 10 / batch: 7345941 quantity: 10.Were evaluated and submitted to validated test and no deviation were observed.Based on sample evaluation and tests performed it was not possible confirm the complaint.Thus it is not possible confirm the defect of this complaint was related of bd process.

Event Description

It was reported that the bd plastipak¿ 3ml luer-lok¿ syringes had damaged stoppers prior to use.

• Brand Name: BD PLASTIPAK¿ 3ML LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8206262
• MDR Text Key: 131774101
• Report Number: 3003916417-2018-00369
• 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: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 990174
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/13/2018; 12/13/2018
• Supplement Dates FDA Received: 01/25/2019; 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other