MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML REG PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problems Break (1069); Defective Component (2292)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.

Event Description

Materials: 306546 batch#: 3351337.It was reported by the customer that good morning.Last friday, we had a safety event reported for bd item # 306546 (bd posiflush¿ prefilled normal saline flush syringe, 10 ml).Let¿s identify this as bd 264, as a reference number.The defective product has been discarded by the clinicians.Based on the information provided below, could you start a product quality report? bd 264: reported date: 02/16/2024; event date: 02/16/2024; item number: 306546; lot number: 3351337; item retained in defect depot?: no; picture: no; patient harm: none; area: g20 (formerly g12 sw) (alk).Event details: ¿flushed a patent picc line with a prefilled saline syringe using push pause technique and the flush syringe plunger piece cracked in half creating dangerous sharp edges that could have punctured through the users skin.¿ verbatim: good morning.Last friday, we had a safety event reported for bd item # 306546 (bd posiflush¿ prefilled normal saline flush syringe, 10 ml).Let¿s identify this as bd 264, as a reference number.The defective product has been discarded by the clinicians.Based on the information provided below, could you start a product quality report? bd 264: reported date: 02/16/2024; event date: 02/16/2024; item number: 306546; lot number: 3351337; item retained in defect depot?: no; picture: no; patient harm: none; area: g20 (formerly g12 sw) (alk).Event details: ¿flushed a patent picc line with a pre filled saline syringe using push pause technique and the flush syringe plunger piece cracked in half creating dangerous sharp edges that could have punctured through the users skin.¿.

Manufacturer Narrative

(b)(4).Follow up : a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3351337.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.H3 other text : see h10 narrative.

Event Description

No additional information received: materials: 306546, batch#: 3351337.It was reported by the customer that good morning.Last friday, we had a safety event reported for bd item # 306546 (bd posiflush¿ prefilled normal saline flush syringe, 10 ml).Let¿s identify this as bd 264, as a reference number.The defective product has been discarded by the clinicians.Based on the information provided below, could you start a product quality report? bd 264: reported date: 02/16/2024; event date: 02/16/2024; item number: 306546; lot number: 3351337; item retained in defect depot?: no; picture: no; patient harm: none; area: g20 (formerly g12 sw) (alk).Event details: ¿flushed a patent picc line with a prefilled saline syringe using push pause technique and the flush syringe plunger piece cracked in half creating dangerous sharp edges that could have punctured through the users skin.¿ verbatim: good morning.Last friday, we had a safety event reported for bd item # 306546 (bd posiflush¿ prefilled normal saline flush syringe, 10 ml).Let¿s identify this as bd 264, as a reference number.The defective product has been discarded by the clinicians.Based on the information provided below, could you start a product quality report? bd 264: reported date: 02/16/2024; event date: 02/16/2024; item number: 306546; lot number: 3351337; item retained in defect depot?: no; picture: no; patient harm: none; area: g20 (formerly g12 sw) (alk).Event details: ¿flushed a patent picc line with a pre filled saline syringe using push pause technique and the flush syringe plunger piece cracked in half creating dangerous sharp edges that could have punctured through the users skin.¿.

• Brand Name: SYRINGE 10ML REG PR SALINE 10ML FILL
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18753618
• MDR Text Key: 336966918
• Report Number: 1911916-2024-00125
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 3351337
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1