MAUDE Adverse Event Report: BECTON DICKINSON BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 6 cases of the bd posiflush¿ normal saline syringe don't have labels on the boxes.The following was received by the customer: customer reported 6 cases of the (b)(4), which doesn't have label on the box so we cannot sell it to their customers.

Manufacturer Narrative

The following fields have been updated due to additional information: device available for eval?: yes returned to manufacturer on: 30-aug-2023 investigation summary: a device history record review was completed for provided material number 306572 and lot number 2188694 (obtained from the provided samples).There were no detected non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, a shipment case containing eight (8) shelf cartons was returned for evaluation by our quality team.Through inspection of the samples, six (6) shelf cartons were found without shelf carton labels.The missing labels most likely resulted from a glitch in the vision system.Since the manufacture of this lot, a correction has been implemented to prevent this issue from recurring.Operators are required to complete a start of shift challenge for the vision system, in order to ensure the system is working correctly.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

It was reported that 6 cases of the bd posiflush¿ normal saline syringe don't have labels on the boxes.The following was received by the customer: customer reported 6 cases of the 306572 which doesn't have label on the box so we cannot sell it to their customers.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17537643
• MDR Text Key: 321726550
• Report Number: 2243072-2023-01435
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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
• Device Operator: Other
• Device Catalogue Number: 306572
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/12/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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