MAUDE Adverse Event Report: HENKE-SASS WOLF, GMBH HSW SYRINGE; SYRINGE, PISTON

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  No Answer Provided  

Event Description

During the current climate with drug shortages, we were unfortunate enough to run low on 60 ml syringes.Our purchaser obtained a different brand syringe (hsw), without the knowledge of the pediatric pharmacy staff.It turned out that these syringes are not compatible with our pediatric syringe infusion pumps, as they are only calibrated to recognize specific brands.Hospital staff should be aware that some substitute products may not be interchangeable.Medication administered to or used by the patient: no; where did the error occur: hospital; hospital unit: pharmacy.(b)(6), access number: (b)(4).

• Brand Name: HSW SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): HENKE-SASS WOLF, GMBH
• MDR Report Key: 8196395
• MDR Text Key: 131766214
• Report Number: MW5082566
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/24/2018

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1