MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB

Model Number 305540

Device Problem Delivered as Unsterile Product (1421)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: occurrence: a complaint history check was performed and this is the 12th related complaint reported with the defect/condition of needle through shield with lot #7226827 regarding item #305540.Customer returned photos of a 1cc, 13mm, 27 allergy syringe with a tray from lot # 7226827.Customer states that the needle had punctured the safety shield and was exposed.The photos were examined and exhibited the cannula through the shield, exposing the cannula, which could lead to a needle stick.Manufacturing ((b)(4)) will be notified of this issue.A review of the device history record was completed for batch #7226827.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted for needle through shield.There were three (3) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure 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.Root cause description: as per investigation completed by manufacturing under investigation child (b)(4), "on (b)(6) 2020, (b)(4) received a complaint, via pictures, from material 305540, batch 7226827.Visual inspection of the pictures showed the cannula protruding through the shield, near the bottom.Process summary: this operation assembles the cannula into the barrel tip and applies adhesive to hold the cannula in the barrel tip.The racks of cannulated barrels then travel through an oven which uses ir light to facilitate adhesive run down and ultraviolet light to cure the adhesive that bonds the cannula to the barrel tip.The cannulated barrels are then conveyed to a machine that inspects for missing cannula, cannula height, point quality, zero line placement, and uv adhesive.It also supplies lube to the cannula, features two lumen blows, assembles the shield to the barrel/cannula assembly, and detects for missing shields.This batch was made before capa (b)(4) which was opened (b)(6) 2018, addressed needle through shield, and was closed effective (b)(6) 2019.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends." rationale: capa (b)(4) which was opened (b)(6) 2018, addressed needle through shield, and was closed effective (b)(6) 2019.

Event Description

It was reported that 7 syringes allergy 1ml w/ndl 27x1/2 rb experienced needle penetration through the shield prior to use.The product defect resulted in 7 different clean needlestick injuries to nurses, but no medical intervention was required as a result.The following information was provided by the initial reporter: a user facility received a complaint for seven bd syringes, 1cc 27 x ½ (item# bd5540 lot# 7226827).Customer states the needles are messed up on these syringes.The customer is not returning the product however they did provide four photos.Needle stick injuries did occur.In fact, that is the way we started realizing that the needles were bent and sticking out of the syringes at an awkward angle.Since we were not aware of this in the beginning, as we put our hands into the boxes to take out new syringes, the nurses would get pricked by the needle.This is before we have even taken the caps off, it is very obvious that the caps cannot even be taken off due to the angle of the bent needle.No patients have had any needle stick injuries.Three nurses received multiple needle stick injuries before we realized this was happening.We are now having to open each container and check all 25 syringes one by one to make sure no needle is sticking out.When we find one, we set it aside with the paper cover (with the lot #) of each container and we definitely do not use them to administer any shots on our patients.This has helped in the process of avoiding the nurses getting pricked but also wastes an inordinate amount of time as have to eye each syringe individually and check for bent needles before placing them into allergy syringe bin.

• Brand Name: SYRINGE ALLERGY 1ML W/NDL 27X1/2 RB
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 10063681
• MDR Text Key: 195957790
• Report Number: 1920898-2020-00527
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903055402
• UDI-Public: 30382903055402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Model Number: 305540
• Device Catalogue Number: 305540
• Device Lot Number: 7226827
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other