MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SURESCRUB¿ PRE-FILLED SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number	306559
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd posiflush¿ surescrub¿ pre-filled syringe had no label on it.The following information was provided by the initial reporter, translated from portuguese: "no impression on the cylinder body.As there was no print on the syringe, it was not possible to identify the batch.".
Event or Problem Description
It was reported that the bd posiflush¿ surescrub¿ pre-filled syringe had no label on it.The following information was provided by the initial reporter, translated from portuguese: "no impression on the cylinder body.As there was no print on the syringe, it was not possible to identify the batch.".
Additional Manufacturer Narrative
H6: investigation summary: to aid in the investigation of this issue, one (1) picture sample was provided for evaluation by our quality engineer team.Upon examination of the picture, a prefilled syringe was observed without a label; however, discoloration or cloudiness of the saline solution could not be confirmed through the picture.Per the picture received, the plunger rod mold number confirms that the product was produced on manufacturing line 4 at the bd fraga manufacturing plant.The first batch manufactured for material 306565 (posiflush 10ml latin america) on line 4 was produced in october 2021 and the las batch was manufactured in august 2022.The production history records were reviewed for that period of time, and no abnormalities were identified that could have contributed to this incident.Based on the provided information, the batch number is unknown for this incident with a reported material of 306559.If additional information becomes available to further clarify the material and batch affected, additional investigation results may be possible.Vision systems are in place during the production process which detect issues related to barrel labels.It is possible that an issue occurred after the vision system, during the double rejection station.If a syringe has no label, the rejection system must reject it.However, if there is a failure in the rejection station, the machine stops.The operator must check the cause of the stoppage and remove the defective samples.H3 other text : see h10.

• Brand Name: BD POSIFLUSH¿ SURESCRUB¿ PRE-FILLED SYRINGE
• Common Device Name: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16393994
• Report Number: 1911916-2023-00080
• Device Sequence Number: 6375664
• Product Code: NGT
• UDI-Device Identifier: 00382903065592
• UDI-Public: 00382903065592
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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 Catalogue Number: 306559
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female