MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 5ML SALINE FILL CHINA SP; FLUSH SYRINGE

Catalog Number 306594

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no sample was received.No photo was provided.A review of the device history record was completed for the incident lot and, based on this review.There was no documentation for this type of defect during the entire production run of this batch.Investigation conclusion this is the 1st complaint for lot # 8298505 for this type of defect or symptom.Root cause description root cause_ can¿t be confirmed.Rationale root cause_ can¿t be confirmed.No sample.

Event Description

It was reported that before use of the syringe 5ml saline fill (b)(4) sp the plunger rod was broken.The following information was provided by the initial reporter, translated from (b)(6) to english: at 1500 on (b)(6) 2019, after the infusion was finished, the patient was given a indwelling needle to seal the tube.Under normal operation, a new flush was opened and found the plunger rod broken.

• Brand Name: SYRINGE 5ML SALINE FILL CHINA SP
• Type of Device: FLUSH SYRINGE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9444185
• MDR Text Key: 194206294
• Report Number: 1911916-2019-01296
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8298505
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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
• Patient Outcome(s): Other