MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML SALINE 3ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306544
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a device history record review was completed for provided material number 306544 and lot number 0230934.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, three physical samples and one photo were provided for evaluation by our quality team.The samples came in sealed packaging flow wraps.One has a syringe barrel label and two do not.No other defects or imperfections were observed.In the photo provided it shows two syringes in their packaging flow wrap and both do not have the syringe barrel label.It could be possible for this defect to occur during the stop/start cycle of the labeling machine.It may have been that the label was not placed and not detected in the next processes.Based on the investigation with the sample and photo sample analysis the symptom reported by the customer is confirmed.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.We will continue monitoring the complaint trend for the product and symptom.Probable root cause.It could be possible that during the machine stop/ start cycle the label was not placed and not detected in the next processes.
Event or Problem Description
It was reported that 9 syringe 3ml saline 3ml fill experienced missing scale markings.The following information was provided by the initial reporter: upon opening a box of 0.9% sodium chloride injection  bd posiflush normal saline flush syringe (ref # 306544), 9 syringes were in the sealed plastic overwrap that do not have markings on the syringe to denote contents, lot, exp, or measurements.Below is the information regarding the box the product was in: " 0.9% sodium chloride injection, bd posiflush syringe ref # 306544 " lot 0230934m exp 8/31/2023 " no injuries that we are aware of.
Event or Problem Description
It was reported that 9 syringe 3ml saline 3ml fill experienced missing scale markings.The following information was provided by the initial reporter: upon opening a box of 0.9% sodium chloride injection ¿ bd posiflush normal saline flush syringe (ref # 306544), 9 syringes were in the sealed plastic overwrap that do not have markings on the syringe to denote contents, lot, exp, or measurements.Below is the information regarding the box the product was in: 0.9% sodium chloride injection, bd posiflush syringe ref # 306544 lot 0230934m exp 8/31/2023 no injuries that we are aware of.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-01-27.Investigation summary : a device history record review was completed for provided material number 306544 and lot number 0230934.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, three physical samples and one photo were provided for evaluation by our quality team.The samples came in sealed packaging flow wraps.One has a syringe barrel label and two do not.No other defects or imperfections were observed.In the photo provided it shows two syringes in their packaging flow wrap and both do not have the syringe barrel label.It could be possible for this defect to occur during the stop/start cycle of the labeling machine.It may have been that the label was not placed and not detected in the next processes.Based on the investigation with the sample and photo sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE 3ML SALINE 3ML FILL
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11311742
• Report Number: 1911916-2021-00106
• Device Sequence Number: 14470350
• Product Code: NGT
• UDI-Device Identifier: 00382903065448
• UDI-Public: 00382903065448
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 306544
• Device Lot Number: 0230934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1