MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 3ML LL 200 S/C; PISTON SYRINGE

Catalog Number 309657

Device Problems Mechanical Problem (1384); Connection Problem (2900)

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

Event Date 04/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the syringe 3ml ll 200 s/c experienced a connectivity issue.The following information was provided by the initial reporter material no.309657, batch no.8222973.No additional information is available.Description of issue: customer reported syringe did not pull back on its own from cartridge.Customer tried different cartridge and different syringe.Customer suspects the needle may not screw on well to the syringe, customer not exactly sure what the issue is.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Proceed to step 3.Number of occurrences: 1.Item number.Choose one: 3 ml syringe ¿ 309657, 26 g, 3/8¿ needle ¿ 305110.Product lot number: 8222973.Are samples available for investigation? yes.Does customer authorize bd to contact customer to obtain sample(s)? yes.Did issue cause any injury? if yes, what type of injury? no.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.Resolution: bd might follow up with customer regarding returning syringe/needle.No further distributor follow up is required.Customer used a different needle and completed load successfully without issues.Note: product category = needle/syringe issue.

Event Description

It was reported that the syringe 3ml ll 200 s/c experienced a connectivity issue.The following information was provided by the initial reporter material no.309657, batch no.8222973.No additional information is available.1.Description of issue: customer reported syringe did not pull back on its own from cartridge.Customer tried different cartridge and different syringe.Customer suspects the needle may not screw on well to the syringe, customer not exactly sure what the issue is.2.Did the customer insert the needle into the cartridge and encounter fill resistance? no.Proceed to step 3.3.Number of occurrences: 1.4.Item number choose one: 3 ml syringe ¿ 309657.26 g, 3/8¿ needle ¿ 305110.5.Product lot number: 8222973.6.Are samples available for investigation? yes.Yes.Does customer authorize bd to contact customer to obtain sample(s)? yes.7.Did issue cause any injury? if yes, what type of injury? no 8.Medical intervention needed? if yes, who was the 3rd party and what was the assistance/treatment? no.9.Resolution: bd might follow up with customer regarding returning syringe/needle.No further distributor follow up is required.Customer used a different needle and completed load successfully without issues.10.Note: product category = needle/syringe issue.

Manufacturer Narrative

H.6.Investigation: no samples or photos received for investigation.10 pieces of retention samples were investigated for a visual and functional evaluation of the product to visualize if the defect reported by the customer is present.The retention samples presented compliant results with no visual or functional issues.No root cause since the defect was not confirmed.The lot was inspected according to the current work instruction with satisfactory results for the characteristics required for its approval including functional tests.No non-conforming part that could be attributable to the defect reported by the client was presented.No deviations (quality notifications) were reported during the manufacturing process.

• Brand Name: SYRINGE 3ML LL 200 S/C
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 8615792
• MDR Text Key: 159415152
• Report Number: 9614033-2019-00151
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: 30382903096573
• Combination Product (y/n): N
• PMA/PMN Number: K151766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 309657
• Device Lot Number: 8222973
• Initial Date Manufacturer Received: 04/28/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 04/28/2019
• Supplement Dates FDA Received: 05/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR