MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE CATHETER TIP 2OZ; IRRIGATING SYRINGE

Model Number 309620

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.A device history review could not be completed as no batch number was provided.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.A device history review could not be completed as no batch number was provided.Root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.

Event Description

It was reported that syringe catheter tip 2oz leaked past the stopper.The following information was provided by the initial reporter: "it was reported leaks would occur past the rubber stopper.Per email: please see the product complaint email below (b)(4).Will be able to mail you one of the defective items next week with the lot # information.Will you please send him a return label.Please let me know if you need anything else from me.Thanks so much.Bd item # 309620.Hope you¿re well.Please see this complaint related to the cath tip syringes.I¿ll have one with the package to send to you next week.It sounds like there might be an issue with the machinery involved in construction of these.¿i am concerned for the potential for a medication error resulting from defective equipment.I have noticed a consistent failure of the 60cc syringes in the irrigation sets used to administer crushed meds via ng/og tubes and the like.For several weeks now every syringe i use has leaked quite severely.Even if brand new and using perfect technique, when the syringe is pointed upright after sucking up the fluid, the contents drain out around the plunger.I haven't had a normally functioning one in weeks.I assumed it was a bad lot or something but i am now concerned that if a nurse doesn't notice it in time, incorrect dosages could be administered.¿".

Event Description

It was reported that syringe catheter tip 2oz leaked past the stopper.The following information was provided by the initial reporter: "it was reported leaks would occur past the rubber stopper.Per email: please see the product complaint email below from erlanger in (b)(6).Will be able to mail you one of the defective items next week with the lot # information.Will you please send him a return label.Please let me know if you need anything else from me.Thanks so much.Bd item # 309620.Hope you¿re well.Please see this complaint related to the cath tip syringes.I¿ll have one with the package to send to you next week.It sounds like there might be an issue with the machinery involved in construction of these.¿i am concerned for the potential for a medication error resulting from defective equipment.I have noticed a consistent failure of the 60cc syringes in the irrigation sets used to administer crushed meds via ng/og tubes and the like.For several weeks now every syringe i use has leaked quite severely.Even if brand new and using perfect technique, when the syringe is pointed upright after sucking up the fluid, the contents drain out around the plunger.I haven't had a normally functioning one in weeks.I assumed it was a bad lot or something but i am now concerned that if a nurse doesn't notice it in time, incorrect dosages could be administered.¿.

Manufacturer Narrative

This mdr should be considered cancelled.Additional information was received which determined that the issue did not occur with catalog number.This complaint has been documented under bdi trackwise (b)(4) as this is a bard product.

• Brand Name: SYRINGE CATHETER TIP 2OZ
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10196600
• MDR Text Key: 200450288
• Report Number: 1911916-2020-00583
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 309620
• Device Catalogue Number: 309620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other