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

Catalog Number 396373

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.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.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1007785, expiration date: 2021-02-01, manufacture date: 2018-03-03.Medical device lot #: 1007786, expiration date: 2021-02-01, manufacture date: 2018-03-06.Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd¿ r 87 v infusion set leaked from underneath the dripping chamber.No serious injury or medical intervention was reported.

Manufacturer Narrative

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: yes.A device history review was conducted for lot numbers 1007785 & 1007786, our records determined that this is the third instance of leakage occurring in lot 1007785 and the second occurrence in lot 1007786.According to the sampling plan applied for product performance, these lots were accepted and released without defects being noted during the final assembly or visual inspection of packaged goods.Samples were submitted by the facility for testing and evaluation; the provided samples contained breaches in the drip chamber that were revealed during the course of leakage testing.The most probable root cause for this issue is a molding defect that results in an asymmetrical thickness in the spigot walls, with one side being thinner and therefore weaker than the other.This weakness can result in cracking of the wall during the attachment of the spike during the automated final assembly.To address this issue bd has increased the rate of machine maintenance intervals on all associated machines and added additional maintenance protocols to address the wearing down of critical machine parts.Additionally, bd has notified our supplier of the molding defect and are currently conducting a complete inspection of this component to help mitigate the reoccurrence of this issue while our supplier addresses this situation.

Event Description

It was reported that bd r 87 v infusion set leaked from underneath the dripping chamber.No serious injury or medical intervention was reported.

• Brand Name: BD¿ R 87 V INFUSION SET
• Type of Device: INFUSION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7809711
• MDR Text Key: 118239591
• Report Number: 2243072-2018-01137
• Device Sequence Number: 1
• Product Code: FPK
• 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: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 396373
• Device Lot Number: SEE H.10
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other