MAUDE Adverse Event Report: BD (SUZHOU) BD PEGASUS BL 22GAX0.75IN PRN-CAP Y NON-PVC; INTRAVASCULAR CATHETER

Catalog Number 383726

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

It was reported that bd pegasus bl 22gax0.75in prn-cap y non-pvc had foreign matter the following information was provided by the initial reporter; 2023-11-1 healthcare workers check before using closed anti-needle-stick injury type intravenous indwelling needles, opened the package and found dirty, discarded.Has found the problem feedback manufacturer follow-up processing: has returned the product, and require the manufacturer distributor to provide product inspection and testing reports.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

No additional information provided.

Manufacturer Narrative

1.The complained product is 22g, the product code is 383726, the batch number is unknown, so can not do dhr investigation.2.The customer did not return samples and only provided a photo of the defective sample.From the photo, it can be seen that there is a black foreign matter on the prn of the product, and the component of the foreign matter cannot be confirmed.3.The batch number was unknown, we can not perform retain sample inspection.In summary, the customer did returned any samples, and it is impossible to confirm whether the foreign matter was generated during the production process of prn or the assembly process of finished products.The component of the black foreign matter cannot be confirmed, and the root cause of this complaint cannot be determined.The factory will continue to monitor and monitor the trend of this defect complaint.

• Brand Name: BD PEGASUS BL 22GAX0.75IN PRN-CAP Y NON-PVC
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18275383
• MDR Text Key: 330118468
• Report Number: 3014704491-2023-00796
• 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: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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: 383726
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 02/08/2024
• 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