MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD TUBING SET; EXTENSION SET

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that an unspecified bd tubing set experienced defective/damaged tubing.The following information was provided by the initial reporter: material #: unknown.Batch/ lot #: unknown.Should i still be contacting you when i have a batch of bad tubing to send out?.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-11-06 h6: investigation summary one sample was received for quality investigation.The customer's complaint of tubing defective / damaged could not be verified based on testing of the sample.The sample evaluated is an unidentified bd extension set with filter.The extension set was visually inspected with no defects or damages observed.The sample was then primed with no issue of air in line or occlusion.The sample was leak tested and there was no signs of leakage.A device history record review could not be performed because a model or lot number was not provided by the customer.Root cause analysis could not be performed as no issues were identified with the returned sample.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.See h.10.

Event Description

It was reported that an unspecified bd tubing set experienced defective/damaged tubing.The following information was provided by the initial reporter: material #: unknown batch/ lot #: unknown should i still be contacting you when i have a batch of bad tubing to send out?.

• Brand Name: UNSPECIFIED BD TUBING SET
• Type of Device: EXTENSION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10856027
• MDR Text Key: 226030644
• Report Number: 2243072-2020-01844
• Device Sequence Number: 1
• Product Code: OJA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1