MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 1ML SYRINGE LUER-LOK TIP; IRRIGATING SYRINGE

Model Number 309620

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: an invalid lot # of 62253 was provided.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the bd 1ml syringe luer-lok¿ tip experienced difficult plunger movement.The following information was provided by the initial reporter: material no: 309620, batch no: unknown.Verbatim: we have had many complaints on this syringe and just now starting to complete the mdip.Unfortunately the syringes are sent from the warehouse and we cannot get the lot number from patients.No serious harm was reported.Unfortunately, the device is not available for investigation.Date of incident (yyyy-mm-dd): (b)(6) 2020.Level of harm: no apparent harm - reached patient/person, inconvenient (b)(4) optional report to ((b)(6)): no incident details: multiple complaints - syringes are hard to use.After using for a bit the rubber on the plunger doesn't move and makes use impossible for some.Lubricating plunger will help some, for a short period of time.Frequency of problem: recurring.Device information device name/description: syringe toomey 50ml with 2 ounce catheter manufacturer: becton dickinson (b)(4) inc manufacturer code/model: 309620.

Event Description

It was reported that the bd 1ml syringe luer-lok¿ tip experienced difficult plunger movement.The following information was provided by the initial reporter: material no: 309620 batch no: unknown verbatim: we have had many complaints on this syringe and just now starting to complete the mdip.Unfortunately the syringes are sent from the warehouse and we cannot get the lot number from patients.No serious harm was reported.Unfortunately, the device is not available for investigation.

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.

• Brand Name: BD 1ML SYRINGE LUER-LOK TIP
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10827244
• MDR Text Key: 219320029
• Report Number: 1911916-2020-01025
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• 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: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1