MAUDE Adverse Event Report: BECTON DICKINSON, S.A. SYRINGE 5ML LS 22X1-1/4 AN EMERALD

Catalog Number 30773319

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/29/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 5ml ls 22x1-1/4 an emerald was used and the person received a clean needle stick, but is undergoing a series of inspections for infectious diseases.The following information was provided by the initial reporter: the distributor reported that bibao's 5ml product was used in the (b)(6) cancer hospital-department of hematology.When the product package was opened, the medical staff (nurse) was injured by needle sticks due to the missing needle shield.Hospital requirements: all products of the same batch need to be withdrawn from the hospital; injured personnel must undergo a series of inspections for infectious diseases; bd is required to write a rectification report (how the manufacturer handles this situation) and need to be submitted tomorrow; the distributor stated that this is the second time the problem occurred with the 5ml product, and the hospital stated that if it occurs for the third time, the hospital will no longer use the product.

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided lot number 1902122.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defects and all quality tests were found to be within specification.To aid in the investigation of this issue, picture and physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, the syringe was observed packaged without the needle shield.It has been concluded that the shields were lost during the packaging process due to low fitting force.If the shield is not properly assembled, as the needles moves through the feeder mechanism of the packaging machine, the shield may become detached.To avoid this situation, a needle length detector is set up to reject any product that does not reach a specified distance.For this instance, the faulty product went undetected.The detection system is allocated in the primary packaging machine and inspects one hundred percent of product.The detection system is positioned to detect the absence of product in the cavity, if no needle is attached to the syringe, and if there is no needle shield attached.The accuracy for the no-needle detection is very high (one hundred percent effectivity), but in the case of accuracy for the no needle-shield detection, it can be much more difficult to identify.The system is challenged every 8 hours and our quality team is continuously trying to improve the detection system for identifying needle shield absence.Upon receiving this report for lot 1902122, the production line used was reviewed and it was confirmed that the production line currently has the capability to detect needles without shields.

Event Description

It was reported that syringe 5ml ls 22x1-1/4 an emerald was used and the person received a clean needle stick, but is undergoing a series of inspections for infectious diseases.The following information was provided by the initial reporter: 1.The distributor reported that bibao's 5ml product was used in the sixth ward of henan cancer hospital-department of hematology.When the product package was opened, the medical staff (nurse) was injured by needle sticks due to the missing needle shield.2.Hospital requirements: (1) all products of the same batch need to be withdrawn from the hospital; (2) injured personnel must undergo a series of inspections for infectious diseases; (3) bd is required to write a rectification report (how the manufacturer handles this situation) and need to be submitted tomorrow (4) the distributor stated that this is the second time the problem occurred with the 5ml product, and the hospital stated that if it occurs for the third time, the hospital will no longer use the product.

• Brand Name: SYRINGE 5ML LS 22X1-1/4 AN EMERALD
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• MDR Report Key: 11729710
• MDR Text Key: 262528576
• Report Number: 3002682307-2021-00154
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 30773319
• Device Lot Number: 1902122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention