MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 22X1-1/2 RB; PISTON SYRINGE

Model Number 309574

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Initial date of awareness was 2019-11-08 but the complaint was deemed not reportable.New information from the analysis of the sample prompted re-evaluation of the decision to report the issue on 2020-01-02.

Event Description

It has been reported that the bd¿ syringe 3ml ll w/ndl 22x1-1/2 rb has been found experiencing four occurrences of containing mixed product during use.The following has been provided by the initial reporter: it was reported the needles are dull resulting in pain to the user upon injection.Additionally, it was reported the needle size is different.Verbatim: consumer reported needle is so dull, barely get it through the bottle, he has to use excessive force in insert the needle into the vial at the grey seal of the vial.He uses the testosterone.The same needles when he used it on the skin he was bleeding.He had pain.He did not seek medical attention.He used the alcohol swab to wipe and used the band aid on it.He has refilled the new prescription, it is the same lot# have not used the new box yet.Consumer reported these needle look different shape different , size is different, they are dull.He is getting the same needles like in the past, no changes on the prescription.These needle are not the same.He uses the bd 9574syr/ ndl 3ml 22gx, he has used the same type of needles before.These needles from the box are dull.Sample discarded.Consumer uses the new needle each time, he visually sees the needle to see if it is straight, it looks fine till he has to use it in the vial or skin it feels different.He rotates the injection site.He has been using these needles for years.He has called the pharmacy regarding this and they have suggested this is the only needle he can use it with this medication.

Manufacturer Narrative

H.6.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.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.No corrective actions recommended since samples/photos were not received to confirm the product defect.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.

Event Description

It has been reported that the bd¿ syringe 3ml ll w/ndl 22x1-1/2 rb has been found experiencing four occurrences of containing mixed product during use.The following has been provided by the initial reporter: it was reported the needles are dull resulting in pain to the user upon injection.Additionally, it was reported the needle size is different.Verbatim: consumer reported needle is so dull, barely get it through the bottle, he has to use excessive force in insert the needle into the vial at the grey seal of the vial.He uses the testosterone.The same needles when he used it on the skin he was bleeding.He had pain.He did not seek medical attention.He used the alcohol swab to wipe and used the band aid on it.He has refilled the new prescription, it is the same lot# have not used the new box yet.Consumer reported these needle look different shape different , size is different, they are dull.He is getting the same needles like in the past, no changes on the prescription.These needle are not the same.He uses the bd 9574syr/ ndl 3ml 22gx, he has used the same type of needles before.These needles from the box are dull.Sample discarded.Consumer uses the new needle each time, he visually sees the needle to see if it is straight, it looks fine till he has to use it in the vial or skin it feels different.He rotates the injection site.He has been using these needles for years.He has called the pharmacy regarding this and they have suggested this is the only needle he can use it with this medication.

• Brand Name: BD SYRINGE 3ML LL W/NDL 22X1-1/2 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9555032
• MDR Text Key: 195294224
• Report Number: 1213809-2020-00002
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095743
• UDI-Public: 30382903095743
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: 309574
• Device Catalogue Number: 309574
• Device Lot Number: 8303558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other