MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS 20 G X 1.16 IN; INTRAVASCULAR CATHETER

Catalog Number 383742

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Anxiety (2328); Depression (2361); Blood Loss (2597)

Event Date 10/28/2015

Event Type  Injury  

Manufacturer Narrative

A supplemental report will be filed upon completion of the investigation.

Event Description

It was reported that during an mri, the patient was receiving an infusion at 3 ml/second through the device when the end cap came loose and blood leaked.The patient lost about 40 ml of blood due to the leakage.Blood tests were performed and revealed a normal hemoglobin.The patient stayed in the hospital for about 2 weeks because he/she was "very unsatisfied with the incident".The patient was later diagnosed by the neurologist with anxiety and depression due to the blood leakage.

Manufacturer Narrative

Additional information: describe event or problem - the patient was having a cardiac mri at time of event.The patient's hospitalization was in the cardiology department.Device evaluation: result - a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 4294424.One unused sample of a bd pegasus 20g was received (b)(6) 2015 from lot number 5041010, which is not the reported lot number for this incident.A visual inspection by microscope was performed.No abnormality is found in the in-coming/assembly process and machine maintenance record.No abnormality is found in the in-process inspection.No abnormality is found on the returned sample.The torque was determined by qa inspection and was found within the scope of product requirements.When the end cap is screwed on, no leakage is found under 6 psi and 45 psi inspection and no end cap loosening appeared.Because the material of end cap and extension tubing adapter are different, the shrinkage of the two materials in temperature changes is different.Temperature change and vibration during transportation may lead to lower torque.Therefore, inspection of the connection of the end cap before puncture is a requirement per the product instructions.Conclusion - this incident may be caused by temperature change and vibration during transportation which leads to lowering the torque of the end cap.The end cap connection should be tested prior to use.The inspection of the returned sample meets all standard requirements.However, the customer's complaint cannot be confirmed as the returned sample is not from the same lot as the suspect device used in this incident.An absolute root cause for this incident cannot be determined.See device evaluation in manufacturer narrative.

• Brand Name: BD PEGASUS 20 G X 1.16 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5297796
• MDR Text Key: 33510724
• Report Number: 3006948883-2015-00008
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/18/2015

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: Other
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: 383742
• Device Lot Number: 4294424
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention