MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE CATHETER TIP 2OZ; IRRIGATING SYRINGE

Catalog Number 309620

Device Problem Leak/Splash (1354)

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

Event Date 07/30/2019

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.Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe catheter tip 2oz has been found experiencing leakage during use.The following has been provided by the initial reporter: material no.: unknown.Batch no.: unknown.Item provided: 309620.Batch provided: 8360828.It was reported that the rubber part of the plunger did not have a proper seal.Verbatim: a patient reported that during an infusion, she noticed that not all of the medication was pushed into the tubing for her to infuse.She noticed ~5cc's of medication on the plunger portion of the syringe once infusion was complete.In other words, it sounded like the rubber part of the plunger did not have a proper seal to push entire contents of medication into the tubing and instead a portion of her dose collected on the side where the plunger is on the syringe.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see section h.10.

Event Description

It has been reported that the syringe catheter tip 2oz has been found experiencing leakage during use.The following has been provided by the initial reporter: material no.: unknown.Batch no.: unknown.Item provided: 309620.Batch provided: 8360828.It was reported that the rubber part of the plunger did not have a proper seal.Verbatim: a patient reported that during an infusion, she noticed that not all of the medication was pushed into the tubing for her to infuse.She noticed ~5cc's of medication on the plunger portion of the syringe once infusion was complete.In other words, it sounded like the rubber part of the plunger did not have a proper seal to push entire contents of medication into the tubing and instead a portion of her dose collected on the side where the plunger is on the syringe.

Manufacturer Narrative

Added manufacturer to product grid.Made in columbus.The following information has been updated: d.3.Medical device manufacturer: becton dickinson and company.G.1.Manufacturing location: becton dickinson and company h3 other text : see h.10.

Event Description

It has been reported that the syringe catheter tip 2oz has been found experiencing leakage during use.The following has been provided by the initial reporter: material no.: unknown; batch no.: unknown.Item provided: 309620; batch provided: 8360828.It was reported that the rubber part of the plunger did not have a proper seal.Verbatim: a patient reported that during an infusion, she noticed that not all of the medication was pushed into the tubing for her to infuse.She noticed ~5cc's of medication on the plunger portion of the syringe once infusion was complete.In other words, it sounded like the rubber part of the plunger did not have a proper seal to push entire contents of medication into the tubing and instead a portion of her dose collected on the side where the plunger is on the syringe.

• Brand Name: SYRINGE CATHETER TIP 2OZ
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 8898531
• MDR Text Key: 176258674
• Report Number: 2243072-2019-01726
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: 00382903096206
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/24/2019

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: Other
• Device Catalogue Number: 309620
• Device Lot Number: 8360828
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 07/30/2019; 07/30/2019
• Supplement Dates FDA Received: 08/21/2019; 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other