MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

Catalog Number 309649

Device Problems Physical Resistance (2578); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(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 when drawing up medication using bd plastipak¿ luer-lok¿ syringes difficult plunger movement was found, as stated when they "press the syringe plunger all the way down to make the syringe plunger slide more easily before use, but they still think it is very hard to work with." there was no report of exposure, injury or medical intervention.

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: device returned to manufacture: yes.

Event Description

It was reported when drawing up medication using bd plastipak luer-lok syringes difficult plunger movement was found, as stated when they "press the syringe plunger all the way down to make the syringe plunger slide more easily before use, but they still think it is very hard to work with." there was no report of exposure, injury or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: two sealed packaged 3ml syringes confirmed to be from batch #7338532,(b)(4).And two sealed packaged 5ml syringes were received 7338674 (b)(4).They were visually evaluated.No visual defects were observed.The samples were tested for breakout and sustaining forces.All forces were well within the specification for the two products.The plunger movement was subjectively evaluated and was observed to be smooth as designed.No defects were confirmed in the samples received, therefore root cause is not determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Investigation conclusion: unable to determine a root cause.

Event Description

It was reported when drawing up medication using bd plastipak¿ luer-lok¿ syringes difficult plunger movement was found, as stated when they "press the syringe plunger all the way down to make the syringe plunger slide more easily before use, but they still think it is very hard to work with." there was no report of exposure, injury or medical intervention.

• Brand Name: BD PLASTIPAK¿ LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7612331
• MDR Text Key: 111853074
• Report Number: 1213809-2018-00356
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096498
• UDI-Public: 30382903096498
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 309649
• Device Lot Number: 7338674
• Date Manufacturer Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other