MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 10ML SALINE FILL CHINA SP; PISTON SYRINGE

Catalog Number 306595

Device Problem Volume Accuracy Problem (1675)

Patient Problem Syncope (1610)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The physical samples are in the sealed packaging blister and visual inspection was performed finding no damages or foreign matter.The clarity is also good.One photo was provided and it shows of the samples received.As no defects were observed, a cause for this defect could not be provided based on the investigation and with the sample/ photo sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.Probable root cause is unknown.It is recommended that the bd china medical function contacts the hospital to have better understanding of the patient symptoms before, during and after use of the product.

Event Description

It was reported that a syringe 10ml saline fill china sp had incorrect barrel label placement resulting in serious injury during use.The following was reported by the initial reporter: "the patient undergoes picc maintenance in the outpatient clinic.During the maintenance process, a bolus of 10ml flush was injected.After the bolus, the patient fainted immediately.The patient is currently transferred to the emergency department.The specific situation requires follow-up.The patient used catheter is a bd three-way valve picc.It have communicated with the head nurse of the emergency department.After treatment by the nursing department, the performance of the patient's family is relatively stable.The flush used by the patient was kept by the hospital.Retrieve 5 products of the same batch number.The rest has been temporarily not used by the hospital.5 samples were retrieved at random.It was found that label was stuck aslant with glue on the surface.

• Brand Name: SYRINGE 10ML SALINE FILL CHINA SP
• Type of Device: PISTON 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 ; 8015296192
• MDR Report Key: 11066917
• MDR Text Key: 223459256
• Report Number: 1911916-2020-01137
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 306595
• Device Lot Number: 0066390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2020
• 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): Required Intervention