MAUDE Adverse Event Report: BECTON DICKINSON BD¿ R 87 P INFUSION SET

Catalog Number 396351

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A 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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that liquid leaked from the bd¿ r 87 p infusion set air vent cap.

Manufacturer Narrative

Investigation summary: sample sent/received of iv set p 150 cm pvc l-l catalog 396351 with lot number unknown.According to issue stated by customer ¿according to the doctor's office who used the device the liquid leaked out from the air vent¿ we can confirm this defect.The sample received was tested according to procedure smp21.02.10sp and after a few minutes the sample star to leak from the vent area, this defect it is caused during the assembly on the vent plug equipment due that it did not center correctly the vent plug and caused this kind of leakage.Review of dhr could not be performed due that no lot number was provided.Reviewing our pfmea¿s rm.35.00, there are proper controls in place to detect product malfunctions.This product it is not anymore produced at the nogales bd site.Root cause: the root cause it is related to the assembly equipment , due that if the filter it is not correctly centered on the vent plug it could cause this kind of defect.

Event Description

It was reported that liquid leaked from the bd¿ r 87 p infusion set air vent cap.

• Brand Name: BD¿ R 87 P INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8206175
• MDR Text Key: 131914046
• Report Number: 2243072-2018-01857
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Report Date: 03/12/2019

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: 396351
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/31/2018
• Supplement Dates Manufacturer Received: 12/11/2018
• Supplement Dates FDA Received: 03/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other