MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY SYRINGE 2OZ CATH TIP BNS; IRRIGATING SYRINGE

Catalog Number 301037

Device Problem Volume Accuracy Problem (1675)

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

Event Date 10/29/2019

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.

Event Description

It has been reported that the syringe 2oz cath tip bns has been found experiencing 23 occurrences of scale marking issues before use.The following has been provided by the initial reporter: it was reported that the scale markings were blurred on the syringes.Event description per attached email states: the last 3 orders they received from (b)(6) to (b)(6) of 2019 for 2,500 pieces each they found syringes with blurred graduation lines of 2,500 pcs.They found 23 defected ones.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported 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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.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.H3 other text : see section h.10.

Event Description

It has been reported that the syringe 2oz cath tip bns has been found experiencing 23 occurrences of scale marking issues before use.The following has been provided by the initial reporter: it was reported that the scale markings were blurred on the syringes.Event description per attached email states: the last 3 orders they received from march to july of 2019 for (b)(4) each they found syringes with blurred graduation lines.Of (b)(4).They found 23 defected ones.

• Brand Name: SYRINGE 2OZ CATH TIP BNS
• Type of Device: IRRIGATING SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9318669
• MDR Text Key: 194823759
• Report Number: 1911916-2019-01203
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 301037
• Device Lot Number: 8186532
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other