MAUDE Adverse Event Report: BECTON DICKINSON BD SYRINGE DN INDIA BP

Catalog Number 303082

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product are (b)(4).These site are an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed, and the (b)(4) fda registration number has been used for the manufacture report number.Initial reporter phone #: (b)(6).Additional reported phone #: (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 bd¿ syringe dn india bp had dust particle inside.The following information was provided by the initial reporter: ¿ in side syringe found with dust particles.¿.

Manufacturer Narrative

H.6.Investigation summary: the dhr was reviewed and no ncp or qn was raised on this lot during manufacturing and production of the lot number 17d3081 until lot release.No photograph and customer return sample are not available for investigation.The team reviewed the retention samples.The retention sample did not show any defect reported by the customer thus the complaint is not confirmed.Conclusion(s): this kind of defect is usually found when the distributor is unaware of the proper storage conditions required for the product to be safe and sterile.As a corrective action, we will inform the business team to update the distribution centers about the proper storage conditions.Complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.

Event Description

It was reported that a bd¿ syringe dn india bp had dust particle inside.The following information was provided by the initial reporter: ¿ in side syringe found with dust particals.¿.

• Brand Name: BD SYRINGE DN INDIA BP
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8488003
• MDR Text Key: 141332856
• Report Number: 2243072-2019-00660
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 303082
• Device Lot Number: 17D3081
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/05/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other