MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CONTAINMENT TUBE

Catalog Number UNKNOWN

Device Problem Short Fill (1575)

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

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It has been reported that the unspecified bd¿ containment tube has been found experiencing underfill during use.The following has been provided by the initial reporter: material no.Unknown batch no.Unknown.It was reported that tubes would not fill properly.Customer noted when she tried to fill the tube, the blood was stopped halfway.She used approx.5 or 6 from the box and all were defective.

Event Description

It has been reported that the unspecified bd¿ containment tube has been found experiencing underfill during use.The following has been provided by the initial reporter: material no.Unknown; batch no.Unknown.It was reported that tubes would not fill properly.Customer noted when she tried to fill the tube, the blood was stopped halfway - she used approx.5 or 6 from the box and all were defective.

Manufacturer Narrative

Investigation summary: the customer did not provide bd pas with product catalog number or lot number information, when requested.After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

• Brand Name: UNSPECIFIED BD¿ CONTAINMENT TUBE
• Type of Device: CONTAINMENT TUBE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9285524
• MDR Text Key: 173453736
• Report Number: 2243072-2019-02482
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other