MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE WITH NEEDLE

Catalog Number 990146

Device Problem Gas/Air Leak (2946)

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

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 that a bubble was found on the tip of the bd plastipak¿ syringe with needle before use.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that a bubble was found on the tip of the bd plastipak syringe with needle before use.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

No samples were returned in support of this complaint.However, a photograph was returned and it was verified that the appearance of bubbles occurs within the thickness of the wall of the luer (red region of the image).Thus, there is no risk of the bubble staying against the wall internal or external to the luer (green region).The bubble could rupture in case there is a deliberate effort of some tool through the inner diameter of the luer, the fact could occur even without the presence of the bubble.In this way we conclude that the bubble is an aesthetic defect and there is no risk to the patient in use.A corrective action proposed to address the matter will be part of the research report.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.The 1ml barrel component is produced by the plastic injection process, where heated plastic material is injected against a mold for forming the product.The investigation has led us to conclude that the flow of the plastic material in the luer region is slightly different than the rest of the product and that for this reason can cause bubbles.Due to an it issue beginning on (b)(6) 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: no.

• Brand Name: BD PLASTIPAK¿ SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7722784
• MDR Text Key: 115368699
• Report Number: 3003916417-2018-00168
• 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: 08/27/2018

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: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 990146
• Device Lot Number: 7333675
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 07/26/2018
• Supplement Dates Manufacturer Received: 07/04/2018
• Supplement Dates FDA Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other