MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD 1ML SYRINGE LUER-LOK¿ TIP; IRRIGATING SYRINGE

Model Number 309620

Device Problem Leak/Splash (1354)

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

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples or photos were received; therefore, sample analysis could not be performed and the condition reported by the customer could not be confirmed.Based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of tip breakage for lot #9086512 item #309620.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Root cause description: based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed.Therefore, a potential root cause(s) cannot be determined.Rationale: based on the investigation conclusion and without a sample to analyze, the condition reported by the customer could not be confirmed.Therefore, no corrective or preventative actions are proposed in the scope of this complaint.

Event Description

Material no.: 309620, batch no.: 9086512.It was reported that before use of the bd 1ml syringe luer-lok¿ tip the tips of the catheter were found broken off.The following information was provided by the initial reporter: tips were found broken off.

Manufacturer Narrative

H.6.Investigation summary: two (2) samples were received for investigation in sealed blister packs.The returned samples were visually examined using unaided vision.Both returned samples had the syringe tips broken off near the shoulder of the barrel.As both tips were in the blister packs the damage occurred after the syringes were sealed in the blister packs.Both tips were completely broken off with the tips still intact indicating that a sharp sudden force was applied to the tips where the shoulder transitions into the tip.As both tips were in the blister packs the damage occurred after the syringes were sealed in the blister packs.Both tips were completely broken off with the tips still intact indicating that a sharp sudden force was applied to the tips where the shoulder transitions into the tip.As the blister packs had seen additional handling where the damage occurred cannot be determined; therefore, a root cause cannot be determined.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Bd acknowledges that the returned samples had syringes which had tips broken off.This is the first (1st) reported complaint with two (2) occurrences.These two (2) occurrences out of a batch size of one hundred thirty-four thousand four hundred (134,400) which equals an occurrence rate of 0.0015%.Therefore, no corrective or preventative actions are proposed in the scope of this complaint.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.H3 other text : see section h.10.

Event Description

Material no.: 309620; batch no.: 9086512.It was reported that before use of the bd 1ml syringe luer-lok¿ tip the tips of the catheter were found broken off.The following information was provided by the initial reporter: tips were found broken off.

• Brand Name: BD 1ML SYRINGE LUER-LOK¿ TIP
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9437553
• MDR Text Key: 194981000
• Report Number: 1911916-2019-01290
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 01/22/2020

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: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 309620
• Device Catalogue Number: 309620
• Device Lot Number: 9086512
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 11/15/2019
• Supplement Dates FDA Received: 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other