MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SP SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/28/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that 4 bd posiflush¿ sp saline syringes had difficult plunger movement during the saline flush.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i have 4+ cases of ref# 306547 (lot# 2237672) that we removed from inventory due to complaints of the syringe sticking when administering the flush.I happened on multiple occasions and all instances where linked to this lot number.Additional information received on 13 july.-could you please advise the occurrence date for the incident? (b)(6) 2023.Could you please provide detail of the incident? a nurse started an iv on a patient and flushed it.After administering 2ml of the 10ml flush the syringe plunger stopped.After removing the syringe she tried to push on the syringe plunger and she stated it was ¿rock hard¿ and the saline couldn¿t be flushed from the syringe.This was noted on several occasions.Is there any adverse event on patient? no.Is there any medical intervention needed due to the incident? no.".

Manufacturer Narrative

H6: investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.H3 other text : see h10.

Event Description

It was reported that 4 bd posiflush¿ sp saline syringes had difficult plunger movement during the saline flush.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "i have 4+ cases of ref# 306547 (lot# 2237672) that we removed from inventory due to complaints of the syringe sticking when administering the flush.I happened on multiple occasions and all instances where linked to this lot number.Additional information received on 13 july: -could you please advise the occurrence date for the incident? 6-8-2023 -could you please provide detail of the incident? a nurse started an iv on a patient and flushed it, after administering 2ml of the 10ml flush the syringe plunger stopped.After removing the syringe she tried to push on the syringe plunger and she stated it was ¿rock hard¿ and the saline couldn¿t be flushed from the syringe.This was noted on several occasions.-is there any adverse event on patient? no.-is there any medical intervention needed due to the incident? no".

• Brand Name: BD POSIFLUSH¿ SP SALINE SYRINGE
• Type of Device: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17452520
• MDR Text Key: 321436475
• Report Number: 1911916-2023-00547
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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: 306547
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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