MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE 26X1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 305111

Device Problem Complete Blockage (1094)

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

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: three samples were received.They all came in opened packaging blister.They have the plastic shield.Each of them was connected to a syringe with saline solution and a functional test was performed.They all passed.No clogging was observed, therefore failure mode could not be verified and root cause could not be determined.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.A device history record review could not be completed as no batch number was provided.Investigation conclusion: a device history record review could not be completed as no batch number was provided.Root cause description: can¿t be confirmed.Rationale: capa not required at this time.

Event Description

It has been reported that the bd¿ needle 26x1/2 rb has been found blocked during use.The following has been provided by the initial reporter: material no.: 305110 batch no.: unknown.It was reported the customer was able to fill the syringe but was unable to push the insulin out of the syringe.Additionally, it was reported that she was unable to draw insulin out of the vial until she changed the needle.Verbatim: description of issue: customer reported about a week ago she was able to fill the syringe with insulin and fill the cartridge but when she tried to push out the rest of the insulin that was in the syringe back into the insulin vial she was not able to push it out.Customer reported another instance today where she was unable to draw insulin out of the vial until she changed the needle.Number of occurrences: 2.Item number: bd 26 g, 3/8¿ needle ¿ 305110.

Event Description

It has been reported that the bd¿ needle 26x1/2 rb has been found blocked during use.The following has been provided by the initial reporter: material no.: 305110, batch no.: unknown.It was reported the customer was able to fill the syringe but was unable to push the insulin out of the syringe.Additionally, it was reported that she was unable to draw insulin out of the vial until she changed the needle.Verbatim: description of issue: customer reported about a week ago she was able to fill the syringe with insulin and fill the cartridge but when she tried to push out the rest of the insulin that was in the syringe back into the insulin vial she was not able to push it out.Customer reported another instance today where she was unable to draw insulin out of the vial until she changed the needle number of occurrences: 2.Item number: bd 26 g, 3/8¿ needle ¿ 305110.

Manufacturer Narrative

Change in reportability.This complaint is no longer reportable.This mfr.Report # 1911916-2019-01335 is void.H3 other text : see h.10.

• Brand Name: BD¿ NEEDLE 26X1/2 RB
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9521875
• MDR Text Key: 193655043
• Report Number: 1911916-2019-01335
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051114
• UDI-Public: 30382903051114
• Combination Product (y/n): N
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: Lay User/Patient
• Device Model Number: 305111
• Device Catalogue Number: 305111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR