MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 23X1 RB; PISTON SYRINGE

Catalog Number 305271

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

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 one syringe integra 3ml w/ndl 23x1 rb has been found experiencing needle retraction failure use.The following has been provided by the initial reporter: i would like to inform you that i received a needlestick injury whilst trying to retract a needle into the syringe, that was manufactured and sold by your company.The procedure was performed as per policy and education with integra syringe.I now have to wait for results of tests to find out if i have contracted anything from the client, who has been treated for (b)(6).Needle didn't retract after giving injection despite pressing on the plunger repeatedly.Placed needle into tray unretracted and the agitated patient managed to get it into her leg.

Event Description

It has been reported that one syringe integra 3ml w/ndl 23x1 rb has been found experiencing needle retraction failure use.The following has been provided by the initial reporter: i would like to inform you that i received a needlestick injury whilst trying to retract a needle into the syringe, that was manufactured and sold by your company.The procedure was performed as per policy and education with integra syringe.I now have to wait for results of tests to find out if i have contracted anything from the client, who has been treated for hep c.Needle didn't retract after giving injection despite pressing on the plunger repeatedly.Placed needle into tray unretracted and the agitated patient managed to get it into her leg.

Manufacturer Narrative

Investigation: two sealed packaged 3ml integra syringe were received, confirmed to be from batch #8092759 (p/n 305271).The samples arrived inside a partially crushed opened sharps container.They were visually evaluated.No visual defects were observed.The two samples were tested for needle activation cut forces per procedure.Both samples returned normal force results within design specification parameters.No issues were noted during the testing.The reported defect was not identified in the returned samples.During production of one of the reported batches, an issue was identified and additional measures were taken to assure release of the product.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 23X1 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9167366
• MDR Text Key: 170541000
• Report Number: 1213809-2019-01012
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: 30382903052715
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305271
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention