MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 393226

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/22/2021

Event Type  malfunction  

Event Description

It was reported that 7 bd venflon pro safety 18ga 1.3mm od 32mm l leaked from the injection port.The following information was provided by the initial reporter: "injection port leaking, patient's blood loss.".

Manufacturer Narrative

Initial reporter phone number: (b)(6) multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1176229, medical device expiration date: 2024-06-30, device manufacture date: 2021-08-06; medical device lot #: 0275631, medical device expiration date: 2023-09-30, device manufacture date: 2020-10-01; medical device lot #: 0081678, medical device expiration date: 2023-03-31, device manufacture date: 2020-03-21; medical device lot #: 1021193, medical device expiration date: 2024-01-31, device manufacture date: 2021-02-17; medical device lot #: 1077006, medical device expiration date: 2024-03-31, device manufacture date: 2021-05-03; medical device lot #: 1049250, medical device expiration date: 2024-02-29, device manufacture date: 2021-03-16.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation: one sample was received by our quality team for evaluation.The sample was observed to be contaminated with blood.After decontamination, the sample was subjected to visual inspection and the catheter adapter leak test.Leakage was observed from the injection port.A foreign matter was observed to be stuck between the valve and the cannula hub at the injection port.The sample was sent to x-ray for analysis.Foreign matter was observed between the valve and cannula hub at the injection port.The valve was extracted out and sent to laboratory test for analysis of the foreign matter.The foreign matter appeared to be a solid transparent object.Based on the laboratory test report, the foreign matter on the valve could possibly be a silicate-based material, likely to be a type of glass material.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The manufacturing process was reviewed and there are no silicate-based materials used in the valve insertion to the cannula hub process.Therefore, the foreign glass material could be introduced out of the manufacturing facilities.The probable root cause of the leakage could be due to the glass material which was observed stuck between the valve and cannula hub at the injection port.Due to the presence of the glass material, the valve was unable to close properly and resulted in leakage from the injection port.The glass material could have gotten stuck between the valve and the cannula hub during product application with other silicate-based device or apparatus (for example: medicine in ampoules).As it is not possible to confirm how the product has been used, the root cause cannot be confirmed.H3 other text : see h.10.

Event Description

It was reported that 7 bd venflon pro safety 18ga 1.3mm od 32mm l leaked from the injection port.The following information was provided by the initial reporter: "injection port leaking, patient's blood loss".

• Brand Name: BD VENFLON PRO SAFETY 18GA 1.3MM OD 32MM L
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12849037
• MDR Text Key: 286115725
• Report Number: 8041187-2021-00990
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

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: 393226
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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